Transcatheter deliverable prosthetic heart valves and methods of delivery

ABSTRACT

A prosthetic valve includes a frame and a flow control component. The frame has an aperture extending through the frame about a central axis. The flow control component is mounted within the aperture and is configured to permit blood flow in a first direction approximately parallel to the vertical axis from an inflow end to an outflow end of the flow control component and to block blood flow in a second direction, opposite the first direction. The frame has an expanded configuration with a first height along the central axis, a first lateral width along a lateral axis perpendicular to the central axis, and a first longitudinal length along a longitudinal axis perpendicular to the central axis and the lateral axis. The frame has a compressed configuration with a second height less than the first height and a second lateral width less than the first lateral width.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationSerial No. PCT/US2019/051957, entitled “Transcatheter DeliverableProsthetic Heart Valves and Methods of Delivery,” filed Sep. 19, 2019,the disclosure of which is incorporated herein by reference in itsentirety.

International Patent Application Serial No. PCT/US2019/051957 is acontinuation-in-part of U.S. patent application Ser. No. 16/155,890,entitled “Orthogonally Delivered Transcatheter Heart Valve Replacement,”filed Oct. 10, 2018 (now U.S. Pat. No. 10,321,995), which claimspriority to and the benefit of U.S. Provisional Patent Application Ser.No. 62/766,611, entitled “Side-Loading Transcatheter Heart ValveReplacement,” filed Sep. 20, 2018, and is a continuation-in-part of U.S.patent application Ser. No. 16/163,577, entitled “Orthogonally DeliveredTranscatheter Heart Valve Frame for Valve in Valve Prostheses,” filedOct. 18, 2018 (now U.S. Pat. No. 11,071,627), the disclosure of each ofwhich is incorporated herein by reference in its entirety.

International Patent Application Serial No. PCT/US2019/051957 alsoclaims priority to and the benefit of U.S. Provisional PatentApplication Ser. No. 62/766,611, entitled “Side-Loading TranscatheterHeart Valve Replacement,” filed Sep. 20, 2018; U.S. Provisional PatentApplication Ser. No. 62/737,343, entitled “Side-Loading TranscatheterHeart Valve Replacement,” filed Sep. 27, 2018; U.S. Provisional PatentApplication Ser. No. 62/749,121, entitled “Guidewire Delivery ofTricuspid Valve,” filed Oct. 22, 2018; and U.S. Provisional PatentApplication Ser. No. 62/777,070, entitled “Compression Capable AnnularFrames for Orthogonal Delivery of Transcatheter Heart ValveReplacement,” filed Dec. 8, 2018, the disclosure of each of which isincorporated herein by reference in its entirety.

This application is also a continuation-in-part of U.S. patentapplication Ser. No. 16/449,420, entitled “Compression Capable AnnularFrames for Side Delivery of Transcatheter Heart Valve Replacement,”filed Jun. 23, 2019, which claims priority to and the benefit of U.S.Provisional Patent Application Ser. No. 62/777,070, filed Dec. 8, 2018,the disclosure of each of which is incorporated herein by reference inits entirety.

This application is also a continuation-in-part of U.S. patentapplication Ser. No. 16/448,108, entitled “Guidewire Delivery ofTranscatheter Heart Valve,” filed Jun. 21, 2019, which claims priorityto and the benefit of U.S. Provisional Patent Application Ser. No.62/749,121, filed Oct. 22, 2018, the disclosure of each of which isincorporated herein by reference in its entirety.

BACKGROUND

Embodiments are described herein that relate to prosthetic heart valves,and devices and methods for use in the delivery and deployment of suchvalves.

Prosthetic heart valves can pose challenges for delivery and deploymentwithin a heart, particularly for delivery by catheters through thepatient's vasculature rather than through a surgical approach.Traditional valves have a central cylinder axis that is parallel to thelengthwise axis of the delivery catheter and are deployed from the endof the delivery catheter and expanded radially outward from the centralannular axis, in a manner akin to pushing a closed spring-loadedumbrella out of a sleeve to make it spring open. Traditional valves canonly be expanded as large as what the internal diameter of the deliverycatheter will allow. Efforts to increase the expanded diameter oftraditional valves have run into the problems of trying to compress toomuch material and structure into too little space.

A need exists for valves that can be delivered through small diameterdelivery catheters, particularly to native valves such as tricuspidvalves.

SUMMARY

The embodiments described herein relate generally to transcatheterprosthetic valves and methods for delivering transcatheter prostheticvalves. In some embodiments, a prosthetic valve includes a frame and aflow control component. The frame has an aperture extending through theframe about a central axis. The flow control component is mounted withinthe aperture and is configured to permit blood flow in a first directionapproximately parallel to the central axis from an inflow end to anoutflow end of the flow control component and to block blood flow in asecond direction, opposite the first direction. The frame has anexpanded configuration with a first height along the central axis, afirst lateral width along a lateral axis perpendicular to the centralaxis, and a first longitudinal length along a longitudinal axisperpendicular to the central axis and the lateral axis. The frame has acompressed configuration with a second height, less than the firstheight, along the central axis and a second lateral width, less than thefirst lateral width, along the lateral axis.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A-1F are schematic illustrations of a transcatheter prostheticvalve according to an embodiment.

FIGS. 2-4A illustrate a transcatheter prosthetic valve according to anembodiment and being delivered within a delivery catheter to a targettissue, being inserted into a native annulus of the target tissue andbeing deployed in the native annulus of the target tissue, respectively.

FIG. 4B is a partial cut-away view of a transcatheter prosthetic valveshowing an inner valve sleeve thereof according to an embodiment.

FIG. 5 is a side view of a transcatheter prosthetic valve according toan embodiment.

FIGS. 6-9 illustrate a process of delivering the transcatheterprosthetic valve of FIG. 5 to a native annulus of a target tissue.

FIGS. 10-12 are various views of a transcatheter prosthetic valve in acompressed configuration within a delivery catheter according to anembodiment.

FIG. 13 is a partial cross-sectional view of the transcatheterprosthetic valve of FIG. 10.

FIGS. 14A-14C illustrate a transcatheter prosthetic valve beingtransitioned from an expanded configuration (FIG. 14A) to a compressedconfiguration (FIG. 14C) according to an embodiment.

FIG. 15 is a perspective view of the transcatheter prosthetic valve ofFIG. 14A in the compressed configuration within a delivery catheter.

FIGS. 16A-16D illustrate a transcatheter prosthetic valve beingtransitioned from an expanded configuration (FIG. 16A) to a compressedconfiguration (FIG. 16D) according to an embodiment.

FIGS. 17A-17E illustrate a transcatheter prosthetic valve beingtransitioned from an expanded configuration (FIG. 17A) to a compressedconfiguration (FIG. 17E) according to an embodiment.

FIGS. 18A-18D illustrate a transcatheter prosthetic valve beingtransitioned from an expanded configuration (FIG. 18A) to a compressedconfiguration (FIG. 18D) according to an embodiment.

FIGS. 19A-19D illustrate a transcatheter prosthetic valve beingtransitioned from a compressed configuration (FIG. 19A) to an expandedconfiguration (FIG. 19D) according to an embodiment.

FIG. 20 is a side perspective view of a transcatheter prosthetic valveaccording to an embodiment.

FIG. 21 is partial cross-sectional view of the transcatheter prostheticvalve of FIG. 20.

FIG. 22 is an exploded view of a two-panel transcatheter prostheticvalve according to an embodiment.

FIG. 23 is a side view of the two-panel transcatheter prosthetic valveof FIG. 22.

FIG. 24 is a side view of the two-panel transcatheter prosthetic valveof FIG. 22 in a compressed configuration.

FIG. 25 is an exploded view of a two-panel transcatheter prostheticvalve according to an embodiment.

FIG. 26 is a side view of the two-panel transcatheter prosthetic valveof FIG. 25.

FIG. 27 is a side view of the two-panel transcatheter prosthetic valveof FIG. 25 in a compressed configuration.

FIGS. 28 and 29 are a side perspective view and a top view,respectively, of a transcatheter prosthetic valve according to anembodiment.

FIGS. 30 and 31 are a side perspective view and a top view,respectively, of a transcatheter prosthetic valve according to anembodiment.

FIGS. 32A and 32B are side perspective views of a transcatheterprosthetic valve according to an embodiment in an expanded configurationand a collapsed configuration, respectively.

FIGS. 33A-33E illustrate a transcatheter prosthetic valve beingtransitioned from an expanded configuration (FIG. 33A) to a compressedconfiguration (FIG. 33E) according to an embodiment.

FIGS. 34A and 34B illustrate a transcatheter prosthetic valve accordingto an embodiment in a collapsed configuration and an expandedconfiguration, respectively.

FIGS. 35A and 35B illustrate a transcatheter prosthetic valve accordingto an embodiment.

FIGS. 36A and 36B illustrate a transcatheter prosthetic valve accordingto an embodiment.

FIGS. 37A and 37B are a side perspective view and a top perspectiveview, respectively, of a transcatheter prosthetic valve according to anembodiment.

FIGS. 37C and 37D are perspective views of the transcatheter prostheticvalve of FIG. 37A being transitioned to a collapsed configuration.

FIGS. 38A-38C are various views of a transcatheter prosthetic valveaccording to an embodiment.

FIGS. 39 and 40 are side perspective views of a transcatheter prostheticvalve each according to a different embodiment.

FIGS. 41A-41G are various views of one or more portions of atranscatheter prosthetic valve according to embodiments.

FIGS. 42-46 are various views of one or more portions of a wire frame ofa transcatheter prosthetic valve according to embodiments.

FIGS. 47A and 47B are side perspective views of an etched metal alloysheet used to form a frame of a transcatheter prosthetic valve eachaccording to a different embodiment.

FIGS. 48 and 49 are side views of a transcatheter prosthetic valvedeployed in a native annulus of a target tissue each according to adifferent embodiment.

FIG. 50 is side view of a transcatheter prosthetic valve deployed in andanchored to a native annulus of a heart.

FIGS. 51A-51C are various views of a transcatheter prosthetic valveaccording to an embodiment.

FIGS. 51D and 51E illustrate the transcatheter prosthetic valve of FIG.51A at least partially disposed within a delivery catheter.

FIGS. 52A and 52B illustrate a transcatheter prosthetic valve partiallydeployed and fully deployed, respectively, in a native annulus of atarget tissue.

FIGS. 53A-53F are various views of a transcatheter prosthetic valveaccording to an embodiment.

FIGS. 54A-54E are various views of a transcatheter prosthetic valveaccording to an embodiment.

FIG. 55A is a side perspective view of a transcatheter prosthetic valveaccording to an embodiment.

FIG. 55B is a cross-sectional view of the transcatheter prosthetic valveof FIG. 55A.

FIGS. 56A and 56B are side views of a transcatheter prosthetic valveaccording to an embodiment in an expanded configuration and a collapsedconfiguration, respectively.

FIGS. 57A and 57B are side views of a transcatheter prosthetic valveaccording to an embodiment in an expanded configuration and a collapsedconfiguration, respectively.

FIGS. 58A and 58B are a side perspective view and a top view,respectively, of a transcatheter prosthetic valve according to anembodiment.

FIGS. 59 and 60 are side perspective views of a transcatheter prostheticvalve each according to a different embodiment.

FIGS. 61-64 are various views of one or more portions of a wire frame ofa transcatheter prosthetic valve according to embodiments.

FIG. 65A is a top view of a transcatheter prosthetic valve shown withina cross-sectional view of an atrial floor and deployed within a nativeannulus.

FIG. 65B is a bottom view of a transcatheter prosthetic valve shownwithin a cross-section view of a ventricular ceiling and deployed withina native annulus.

FIG. 66 is a side perspective view of a wire frame of a transcatheterprosthetic valve according to an embodiment.

FIG. 67 is a side perspective view of a valve sleeve of a transcatheterprosthetic valve according to an embodiment.

FIG. 68A is a side perspective view of a valve sleeve of a transcatheterprosthetic valve according to an embodiment.

FIG. 68B is a cross-sectional view of the valve sleeve of FIG. 68Adisposed within a frame of the transcatheter prosthetic valve.

FIG. 69 is a side perspective view of a valve sleeve of a transcatheterprosthetic valve according to an embodiment.

FIG. 70A is a side perspective view of a valve sleeve of a transcatheterprosthetic valve according to an embodiment.

FIG. 70B is a cross-sectional view of the valve sleeve of FIG. 70Adisposed within a frame of the transcatheter prosthetic valve.

FIGS. 71A-71C are various views of a transcatheter prosthetic valveaccording to an embodiment.

FIGS. 72A-72C are schematic illustrations of a delivery system fordelivering a transcatheter prosthetic valve according to an embodiment.

FIG. 72D is a flowchart describing a method for delivering atranscatheter prosthetic valve according to an embodiment.

FIG. 73A is an illustration of the human heart anatomy and FIG. 73B isan enlarged illustration of a portion of the human heart anatomy of FIG.73A.

FIG. 74 is an illustration of a transcatheter prosthetic valve deployedwithin a native annulus of the human heart of FIGS. 73A and 73Baccording to an embodiment.

FIGS. 75A-75D, 76A-76C, 77A-77D, and 78A-78D illustrate a process ofdeploying a transcatheter prosthetic valve in a native annulus of thehuman heart each according to a different embodiment.

FIGS. 79A-79E illustrate a transcatheter prosthetic valve beingtransitioned from a compressed configuration (FIG. 79A) to an expandedconfiguration (FIGS. 79D and 79E) according to an embodiment.

FIGS. 80A-80D illustrate a transcatheter prosthetic valve beingtransitioned from a compressed configuration (FIG. 80A) to an expandedconfiguration (FIG. 80D) according to an embodiment.

FIG. 80E is an illustration of a side view of a transcatheter prostheticvalve in a compressed configuration within a delivery catheter, andshowing a secondary catheter configured to move the valve through thedelivery catheter according to an embodiment.

FIGS. 81A-81D are side views of a portion of a secondary catheterincluding a guidewire collar each according to a different embodiment.

FIGS. 82A-82C are schematic illustrations of a delivery system fordelivering a transcatheter prosthetic valve according to an embodiment.

FIG. 82D is a flowchart describing a method for delivering atranscatheter prosthetic valve according to an embodiment.

FIGS. 83A-83F illustrate a process of deploying a transcatheterprosthetic valve in a native annulus of the human heart according to anembodiment.

FIGS. 84A-84H illustrate a process of deploying a transcatheterprosthetic valve in a native annulus of the human heart according to anembodiment.

FIGS. 85A-85F illustrate a process of deploying a transcatheterprosthetic valve in a native annulus of the human heart according to anembodiment.

FIGS. 86A-86F illustrate a process of deploying a transcatheterprosthetic valve in a native annulus of the human heart according to anembodiment.

FIGS. 87A-87E illustrate a process of deploying a transcatheterprosthetic valve in a native annulus of the human heart according to anembodiment.

FIGS. 88A and 88B illustrate a process of deploying a transcatheterprosthetic valve in a native annulus of the human heart according to anembodiment.

FIGS. 89A-89C illustrate a process of deploying a transcatheterprosthetic valve in a native annulus of the human heart according to anembodiment.

FIGS. 90A-90C illustrate a process of anchoring a transcatheterprosthetic valve to a target tissue via a tissue anchor according to anembodiment.

FIGS. 91A-91D are side views of a tissue anchor each according to adifferent embodiment.

FIG. 92A-92D illustrate a process of deploying and anchoring atranscatheter prosthetic valve in a native annulus of a target tissue.

FIG. 93A-93E illustrate a process of deploying and anchoring atranscatheter prosthetic valve in a native annulus of a target tissue.

FIG. 94 is a flowchart describing a method for delivering atranscatheter prosthetic valve according to an embodiment.

FIG. 95 is a flowchart describing a method for loading a transcatheterprosthetic valve into a delivery catheter according to an embodiment.

FIG. 96A is a cross-sectional view of a transcatheter prosthetic valveillustrating a valve sleeve disposed within a frame, according to anembodiment.

FIG. 96B is a side view of the transcatheter prosthetic valve of FIG.96A in an expanded configuration.

FIGS. 96C-96F illustrate a process of deploying the transcatheterprosthetic valve of FIG. 96A into a native annulus of a target tissue.

FIGS. 97A-97C illustrate a process of deploying a transcatheterprosthetic valve to a target tissue via a tissue anchor according to anembodiment.

FIGS. 98A-98C illustrate a process of deploying a transcatheterprosthetic valve to a target tissue via a tissue anchor according to anembodiment.

FIGS. 99A-99D illustrate at least a portion of a transcatheterprosthetic valve according to an embodiment.

FIG. 100 is an illustration of the human heart, showing an approximatelocation of the valves, the atriums, the ventricles, and the pertinentblood vessels that enter and exit the chambers of the heart.

FIGS. 101A-101G illustrate a process of deploying a transcatheterprosthetic valve into a native annulus of a target tissue according toan embodiment.

FIGS. 102A-102D illustrate a process of deploying a transcatheterprosthetic valve into a native annulus of a target tissue according toan embodiment.

FIGS. 103A-103G illustrate a process of deploying a transcatheterprosthetic valve into a native annulus of a human heart according to anembodiment.

FIGS. 104A-104F illustrate a process of deploying a transcatheterprosthetic valve into a native annulus of a human heart according to anembodiment.

DETAILED DESCRIPTION

Disclosed embodiments are directed to an orthogonally deliveredtranscatheter prosthetic valves and/or components thereof, and methodsof manufacturing, loading, delivering, and deploying the transcatheterprosthetic valves and/or components thereof. The transcatheterprosthetic valves have a tubular frame and a flow control componentmounted within a central lumen of the tubular frame. The flow controlcomponent is configured to permit blood flow in a first directionthrough an inflow end of the valve and block blood flow in a seconddirection, opposite the first direction, through an outflow end of thevalve. The valve is compressible and expandable along a long-axissubstantially parallel to a lengthwise cylindrical axis of a deliverycatheter. The valve is configured to transition between a compressedconfiguration for introduction into the body using the deliverycatheter, and an expanded configuration for implanting at a desiredlocation in the body. The valve is configured to permit blood flow in afirst direction through an inflow end of the valve and to block bloodflow in a second direction, opposite the first direction, through anoutflow end of the valve.

In some embodiments, the transcatheter prosthetic valve has thecompressible configuration in a lengthwise or orthogonal directionrelative to the central axis of the flow control component can allow alarge diameter valve (e.g., having a height of about 5-60 mm and adiameter of about 20-80 mm) to be delivered and deployed from theinferior vena cava directly into the mitral or tricuspid valve using,for example, a 24-36Fr delivery catheter and without delivery anddeployment from the delivery catheter at an acute angle of approach.

In some embodiments, the transcatheter prosthetic valve has a centralaxis when in the compressed configuration that is co-axial or at leastsubstantially parallel with the first direction (e.g., the blood flowdirection). In some embodiments, the compressed configuration of thevalve is orthogonal to the first direction. In some embodiments, thelong-axis is oriented at an intersecting angle of between 45-135 degreesto the first direction when in the compressed configuration and/or theexpanded configuration.

In some embodiments, the transcatheter prosthetic valve includes atension arm extending from a distal side of the tubular frame, which canbe used, for example, as a Right Ventricular Outflow Tract (“RVOT”) tab.The tension arm can include a wire loop or wire frame, integrated framesection, or stent, extending from about 10-40 mm away from the tubularframe.

In some embodiments, the transcatheter prosthetic valve includes (i) anupper tension arm attached to a distal upper edge of the tubular frame,the upper tension arm comprised of wire loop or wire frame extendingfrom about 2-20 mm away from the tubular frame, and (ii) a lower tensionarm (e.g., used as a RVOT tab) extending from a distal side of thetubular frame, the lower tension arm comprised of wire loop or wireframe extending from about 10-40 mm away from the tubular frame.

In some embodiments, the transcatheter prosthetic valve includes atleast one tissue anchor connected to the tubular frame for engagingannular tissue.

In some embodiments, the transcatheter prosthetic valve is one of aballoon-inflated valve or a self-expanding valve.

In some embodiments, the tubular frame forms a two-part framework. Afirst part includes a flared atrial cuff joined to a second part thatcomprises cylindrical member/segment. The cuff is joined to thecylindrical member/segment around the circumference of a top edge of thecylindrical member/segment.

In some embodiments, the tubular frame has a side profile of a flat coneshape having a diameter R of 40-80 mm, a diameter r of 20-60 mm, and aheight of 5-60 mm. In some embodiments, the tubular frame has a sideprofile of an hourglass flat conical shape having a top diameter R1 of40-80 mm, a bottom diameter R2 of 50-70 mm, an internal diameter r of20-30 mm, and a height of 5-60 mm. In some embodiments, the tubularframe has an outer diameter of 20-80 mm and an inner diameter of 21-79mm.

In some embodiments, the tubular frame is formed of a braided wire,laser-cut wire, photolithography produced wire cells, 3D printed wirecells, wire cells formed from intermittently connected single strandwires in a wave shape, a zigzag shape, or spiral shape, and/orcombinations thereof, and is covered with a biocompatible material. Insome embodiments, the tubular frame is formed of a plurality ofcompressible wire cells having an orientation and cell geometrysubstantially orthogonal to a central vertical axis of the valve tominimize wire cell strain when the tubular frame is configured in avertical compressed configuration, a rolled compressed configuration, ora folded compressed configuration.

In some embodiments, the tubular frame has a central channel and anouter perimeter wall circumscribing a central vertical axis in anexpanded configuration. The perimeter wall has a front wall portion anda back wall portion connected along a proximal side to a proximal foldarea and connected along a distal side to a distal fold area. The frontwall portion has a front upper collar portion and a front lower bodyportion. The back wall portion has a back upper collar portion and aback lower body portion. In some embodiments, the front lower bodyportion and the back lower body portion in an expanded configurationform a shape selected from a funnel, cylinder, flat cone, or circularhyperboloid. In some embodiments, the proximal fold area and the distalfold area each comprise a sewn seam, a fabric panel, or a rigid hinge.In some embodiments, the proximal fold area and the distal fold areaeach comprise a flexible fabric span without any wire cells.

In some embodiments, the tubular frame has an inner surface covered witha biocompatible material comprising pericardial tissue, and an outersurface covered with a biocompatible material comprising a wovensynthetic polyester material.

In some embodiments, the flow control component has an internal diameterof 20-35 mm and a height of 5-40 mm, and a plurality of leaflets ofpericardial material joined to form a rounded cylinder at an inflow endand having a flat closable aperture at an outflow end. For example, aflow control component can include 2-4 leaflets of pericardial material.

In some embodiments, the flow control component is supported with one ormore longitudinal supports integrated into or mounted upon the flowcontrol component. The one or more longitudinal supports selected fromrigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or semi-rigidbattens, rigid or semi-rigid panels, and combination thereof.

In some embodiments, a delivery system for deployment of thetranscatheter prosthetic valve includes (i) a delivery cathetercomprising an elongated tube with a central lumen; (ii) a hypotubesheathed guidewire assembly having an outer sheath and an innerguidewire shaft configured to push against a guidewire collar on atension arm of a compressed transcatheter prosthetic valve to deliverthe valve; (ii) the transcatheter prosthetic valve having a tension armextending from a distal side of the tubular frame. The tension arm iscomprised of wire loop or wire frame, integrated frame section, orstent, extending about 10-40 mm away from the tubular frame. The tensionarm having a guidewire collar element attached the tension arm, whereinthe guidewire collar element is sized and configured with a guidewireaperture to allow the inner guidewire shaft of the hypotube sheathedguidewire assembly to pass through the guide aperture, and to blockpassage of the outer sheath of the guidewire assembly through theguidewire aperture.

In some embodiments, a method for manufacturing the transcatheterprosthetic valve includes (i) using additive or subtractive metal ormetal-alloy manufacturing to produce the tubular frame, wherein theadditive metal or metal-alloy manufacturing is 3D printing or directmetal laser sintering (powder melt), and wherein the subtractive metalor metal-alloy manufacturing is photolithography, lasersintering/cutting, CNC machining, or electrical discharge machining;(ii) mounting a flow control component within the tubular frame; (iii)covering an outer surface of the tubular frame with a pericardiummaterial or similar biocompatible material.

In some embodiments, a method for orthogonal delivery of thetranscatheter prosthetic valve to a desired location in the bodyincludes (i) advancing a delivery catheter to the desired location inthe body and (ii) delivering the transcatheter prosthetic valve to thedesired location in the body by releasing the valve from the deliverycatheter. The valve being in the compressed configuration when in thedelivery catheter. The valve transitioning to the expanded configurationwhen released from the delivery catheter.

In some embodiments, the method further includes attaching a pullingwire (e.g., a rigid elongated pulling/pushing rod or draw wire) to asidewall of the transcatheter prosthetic valve and pulling the valveinto a tapering fixture or funnel (e.g., attached to a proximal end ofthe delivery catheter) such that the tapering fixture or funnelcompresses or spirals the valve to the compressed configuration forloading into the delivery catheter.

In some embodiments, the method includes releasing the valve from thedelivery catheter by (i) pulling the valve out of the delivery catheterusing the pulling wire that is releasably connected to the distal sideof the valve, wherein advancing the pushing rod away from the deliverycatheter pulls the compressed valve out of the delivery catheter, or(ii) pushing the valve out of the delivery catheter using the pullingwire that is releasably connected to the proximal side of the valve,wherein advancing the pushing rod out of from the delivery catheterpushes the compressed valve out of the delivery catheter.

In some embodiments, the method includes releasing the valve from thedelivery catheter while increasing blood flow during deployment of thevalve by (i) partially releasing the valve from the delivery catheter toestablish blood flow around the partially released valve and blood flowthrough the flow control component; (ii) completely releasing the valvefrom the delivery catheter while maintaining attachment to the valvewith a positioning catheter or the pulling wire to transition to a statewith increased blood flow through the flow control component anddecreased blood flow around the valve; (iii) deploying the valve into afinal mounted position to transition to a state with complete blood flowthrough the flow control component and minimal or no blood flow aroundthe valve; and (iv) disconnecting and withdrawing the positioningcatheter or pulling wire from the valve.

In some embodiments, the method further includes inserting a tension arm(e.g., a RVOT tab) in the RVOT during the transition from partialrelease of the valve to complete release of the valve.

In some embodiments, the method further includes rotating thetranscatheter prosthetic valve using a steerable catheter along an axisparallel to the plane of the valve annulus such that (i) the uppertension arm is conformationally pressure locked against supra-annulartissue and (ii) the lower tension arm is conformationally pressurelocked against sub-annular tissue.

In some embodiments, the method further includes anchoring one or moretissue anchors attached to the valve into annular tissue.

In some embodiments, a method for orthogonal delivery of thetranscatheter prosthetic valve to the desired location in the bodyincludes (i) advancing a first delivery catheter to the desired locationin the body, (ii) delivering the tubular frame to the desired locationin the body by releasing the tubular frame from the delivery catheter,(iii) advancing a second delivery catheter to the desired location inthe body, and (iv) delivering the flow control component into thecentral lumen of the tubular frame. The tubular frame being in thecompressed configuration when in the first delivery catheter and theflow control component being in the compressed configuration when in thesecond delivery catheter. The tubular frame transitioning to theexpanded configuration when released from the first delivery catheterand the flow control component transitioning to the expandedconfiguration when released from the second delivery catheter to mountinto the tubular frame.

In some embodiments, a method for compressing the transcatheterprosthetic valve for lengthwise orthogonal release from a deliverycatheter includes (i) flattening, rolling or folding the valve into acompressed configuration wherein the long-axis of the valve issubstantially parallel to a lengthwise cylindrical axis of the deliverycatheter. In some embodiments, the method includes one of (i)unilaterally rolling the valve into the compressed configuration fromone side of the tubular frame; (ii) bilaterally rolling the valve intothe compressed configuration from two opposing sides of the tubularframe; (iii) flattening the tubular frame into two parallel panels thatare substantially parallel to the long-axis, and then rolling theflattened tubular frame into the compressed configuration; or (iv)flattening the tubular frame along a vertical axis to reduce a verticaldimension of the valve from top to bottom.

In some embodiments, a method for orthogonal delivery of thetranscatheter prosthetic valve to a desired location in the bodyincludes (i) advancing a guidewire to a desired location within a body,said guidewire having an outer sheath and an inner shaft; (ii) advancinga delivery catheter over the guidewire to the desired location; (iii)mounting a valve capsule onto a proximal end of the guidewire, saidvalve capsule containing a compressed valve having a threaded guidewirecollar having an aperture sized to permit the inner shaft of theguidewire to extend through the aperture and to block the outer sheathof the guidewire from extending through the aperture; (iv) loading thevalve capsule into a proximal end of the delivery catheter; (v)advancing the compressed valve from the valve capsule into and through alumen of the delivery catheter to the desired location in the body byadvancing the outer sheath over the inner shaft to deploy the valve atthe desired location.

In some embodiments, a method for orthogonal delivery of thetranscatheter prosthetic valve to a native annulus of a human heart caninclude at least one of (i) advancing the delivery catheter to thetricuspid valve or pulmonary artery of the heart through the inferiorvena cava (IVC) via the femoral vein, (ii) advancing to the tricuspidvalve or pulmonary artery of the heart through the superior vena cava(SVC) via the jugular vein, or (iii) advancing to the mitral valve ofthe heart through a trans-atrial approach, e.g., fossa ovalis or lower,via the IVC-femoral or the SVC jugular approach; and (iv) deliveringtranscatheter prosthetic valve to the native annulus by releasing thevalve from the delivery catheter.

In some embodiments, the method further includes positioning a tensionarm of the transcatheter prosthetic valve into a RVOT of a rightventricle of a human heart. For example, the method can further include(i) positioning a lower tension arm of the valve into the RVOT of theright ventricle and (ii) positioning an upper tension arm—connected tothe lower tension arm—into a supra-annular position such that the uppertension arm provides a supra-annular downward force in the direction ofthe right ventricle and the lower tension arm provides a sub-annularupward force in the direction of the right atrium.

In some embodiments, a prosthetic valve includes a tubular frame, adistal subannular anchoring tension arm, and a flow control component.The tubular frame has a sidewall and an atrial collar attached around atop edge of the sidewall. The distal subannular anchoring tension arm isattached to and extends away from a lower distal sidewall of the tubularframe. The flow control component is mounted within the tubular frameand configured to permit blood flow in a first direction through aninflow end of the prosthetic valve and block blood flow in a seconddirection, opposite the first direction, through an outflow end of theprosthetic valve. The prosthetic valve is compressible to a compressedconfiguration for introduction into the body using a delivery catheterfor implanting at a desired location in the body. The prosthetic valve,in the compressed configuration, has a long-axis oriented at anintersecting angle of between 45-135 degrees to the first direction andsubstantially parallel to a lengthwise cylindrical axis of the lumen ofthe delivery catheter. The prosthetic valve is expandable to an expandedconfiguration having a long-axis oriented at an intersecting angle ofbetween 45-135 degrees to the first direction.

In some embodiments, a prosthetic valve includes a valve frame and aflow control component. The valve frame has an aperture extendingthrough the valve frame along a central axis. The flow control componentis mounted within the aperture and is configured to permit blood flow ina first direction approximately parallel to the central axis from aninflow end to an outflow end of the flow control component and to blockblood flow in a second direction, opposite the first direction. Thevalve frame has an expanded configuration with a first height along thecentral axis, a first lateral width along a lateral axis perpendicularto the central axis, and a first longitudinal length along alongitudinal axis perpendicular to the central axis and the lateralaxis. The valve frame has a compressed configuration with a secondheight, less than the first height, along the central axis and a secondlateral width, less than the first lateral width, along the lateralaxis.

In some embodiments, a frame for a prosthetic valve includes a tubularframe having a central lumen defined by an inner circumferential surfaceof the tubular frame and defining a vertical axis of the tubular frame.The tubular frame has an outer circumferential surface engageable withnative annular tissue. The tubular frame is compressible to a compressedconfiguration for introduction into the body using a delivery catheterfor implanting at a desired location in the body. The valve, incompressed configuration, has a horizontal long-axis oriented at anintersecting angle between 45-135 degrees relative to the vertical axisof the of the tubular frame and substantially parallel to a lengthwisecylindrical axis of a lumen of the delivery catheter when disposedtherein. The valve is expandable to an expanded configuration having ahorizontal long-axis oriented at an intersecting angle between 45-135degrees relative to the vertical axis of the tubular frame.

In some embodiments, a method for delivering a prosthetic valve to anative valve between a ventricle and an atrium of a heart includesadvancing to the atrium of the heart a delivery catheter containing aprosthetic valve. The prosthetic valve includes a tubular frame having aside wall and an atrial collar attached around a top edge of the sidewall, a distal subannular anchoring tension arm attached and extendingdistally away from a lower distal side wall of the tubular frame, and aflow control component mounted within the tubular frame. The flowcontrol component configured to permit blood flow in a first directionthrough an inflow end of the prosthetic valve and block blood flow in asecond direction, opposite the first direction, through an outflow endof the prosthetic valve. The prosthetic valve is disposed in thedelivery catheter in a compressed configuration having a long-axisoriented at an intersecting angle of between 45-135 degrees to the firstdirection and substantially parallel to a length-wise cylindrical axisof the delivery catheter, and expandable to an expanded configurationhaving a long-axis oriented at an intersecting angle of between 45-135degrees to the first direction. The method includes releasing the distalsubannular anchoring tension arm of the prosthetic valve from thedelivery catheter by pulling the tension arm out of the deliverycatheter by pushing away from the delivery catheter a rigid elongatedpushing rod that is releasably connected to the tension arm. The distalsubannular anchoring tension arm is delivered to the ventricle side ofthe annulus of the native valve. The remainder of the prosthetic valveis then released from the delivery catheter to an expanded configurationso that the tubular frame is disposed within the annulus of the nativevalve.

In some embodiments, a method of delivering a prosthetic valve to anannulus of a native valve between a ventricle and an atrium of a heartincludes disposing in the atrium of the heart a distal portion of adelivery catheter having a lumen and a longitudinal axis, with a distalend of the delivery catheter directed towards the annulus of the nativevalve. The prosthetic valve being disposed within the distal portion ofthe delivery catheter in a compressed configuration. The prostheticvalve having a tubular frame with a tension arm coupled thereto and aflow control component mounted within the tubular frame and having anexpanded configuration in which the prosthetic valve is configured topermit blood flow in a first direction through an inflow end of theprosthetic valve and block blood flow in a second direction, oppositethe first direction, through an outflow end of the prosthetic valve. Thetension arm extends laterally from the tubular frame and is disposed onthe ventricle side of the annulus of the native valve when the tubularframe is disposed within the annulus. The prosthetic valve, when in theexpanded configuration, has an extent in any direction lateral to thefirst direction that is larger than a diameter of the lumen of thedistal portion of the delivery catheter. The prosthetic valve, when inthe compressed configuration, is disposed within the distal portion ofthe delivery catheter and is elongated in a longitudinal direction andcompressed in a lateral direction relative to the dimensions of theprosthetic valve in the expanded configuration. The prosthetic valve hasa long axis in the longitudinal direction that is parallel to thelongitudinal axis of the delivery catheter and oriented at anintersecting angle of between 45 and 135 degrees to the first direction,with the tension arm disposed distally in the longitudinal direction,towards the distal end of the delivery catheter. The method furtherincludes releasing the tension arm from the lumen of the catheter. Atleast a distal portion of the tension arm is disposed on the ventricleside of the annulus of the native valve while the distal end of thedelivery catheter remains on the atrium side of the annulus. Theremainder of the prosthetic valve is released from the lumen of thedelivery catheter so that the tubular frame is disposed within theannulus of the native valve.

In some embodiments, a method of delivering a prosthetic valve to anannulus of a native valve between a ventricle and an atrium of a heartincludes disposing in the atrium of the heart a distal portion of adelivery catheter having a lumen and a longitudinal axis, with a distalend of the delivery catheter directed towards the annulus of the nativevalve. The prosthetic valve being disposed within the distal portion ofthe delivery catheter in a compressed configuration. The prostheticvalve having a tubular frame with a tension arm coupled thereto and aflow control component mounted within the tubular frame and having anexpanded configuration in which the prosthetic valve is configured topermit blood flow in a first direction through an inflow end of theprosthetic valve and block blood flow in a second direction, oppositethe first direction, through an outflow end of the prosthetic valve. Thetension arm extends laterally from the tubular frame and is disposed onthe ventricle side of the annulus of the native valve when the tubularframe is disposed within the annulus. The tubular frame is disposedwithin the lumen of the delivery catheter with the tension arm disposedtowards the distal end of the delivery catheter. The method furtherincludes releasing the tension arm from the lumen of the deliverycatheter. At least a distal portion of the tension arm is disposed onthe ventricle side of the annulus of the native valve while the distalend of the delivery catheter remains on the atrium side of the annulus.The remainder of the prosthetic valve is released from the lumen of thedelivery catheter. The prosthetic valve is held at an oblique anglerelative to the annulus of the native valve and blood is allowed to flowfrom the atrium to the ventricle both through the native valve andthrough the prosthetic valve to allow assessment of the function of thenative valve and the prosthetic valve.

In some embodiments, a method for delivering a prosthetic valve includesadvancing, over a guidewire having a diameter, a delivery catheter todispose a distal end of the delivery catheter at a desired locationwithin a body. A proximal end of the guidewire is mounted onto a valvecapsule containing a prosthetic valve in a compressed configuration. Theprosthetic valve has a guidewire collar with an aperture therethroughhaving an internal diameter larger than the diameter of the guidewire.The guidewire is disposed through the aperture of the guidewire collar.The valve capsule is loaded into a proximal end of the deliverycatheter. A pusher is disposed over the guidewire proximal to theprosthetic valve. The pusher has an outside diameter larger than theinternal diameter of the aperture in the guidewire collar. Theprosthetic valve is advanced from the valve capsule into and through alumen of the delivery catheter to the distal end thereof by advancingthe pusher over the guidewire and the prosthetic valve is deployed fromthe distal end of the delivery catheter to the desired location.

In some embodiments, a method of delivering a prosthetic valve to anannulus of a native valve between a ventricle and an atrium of a heartincludes disposing in the atrium of the heart a distal portion of adelivery catheter having a lumen and a longitudinal axis, with a distalend of the delivery catheter directed towards the annulus of the nativevalve. A tubular frame for the prosthetic valve being disposed withinthe lumen of the delivery catheter in a compressed configuration. Thetubular frame defines a central lumen having a central axis and atension arm coupled thereto. The tubular frame has an expandedconfiguration in which the tubular frame. The tubular frame, when in theexpanded configuration, has an extent in any direction lateral to thecentral axis that is larger than a diameter of the lumen of the distalportion of the delivery catheter. The tubular frame, when in thecompressed configuration, is disposed within the distal portion of thedelivery catheter and is elongated in a longitudinal direction andcompressed in a lateral direction relative to the dimensions of thetubular frame in the expanded configuration. The tubular frame has along-axis in the longitudinal direction that is parallel to thelongitudinal axis of the delivery catheter and oriented at anintersecting angle between 45 and 135 degrees relative to the centralaxis with the tension arm disposed distally in the longitudinaldirection, towards the distal end of the delivery catheter. The methodfurther includes releasing the tension arm from the lumen of thecatheter. At least a distal portion of the tension arm is disposed onthe ventricle side of the annulus of the native valve while the distalend of the delivery catheter remains on the atrium side of the annulusand the remainder of the tubular frame is released from the lumen of thedelivery catheter so that the tubular frame is disposed within theannulus of the native valve.

In some embodiments, a prosthetic valve has an annular valve framedefining a central axis and has an expanded configuration with avertical height along the central axis, a lateral width along a lateralaxis perpendicular to the central axis, and a longitudinal length alonga longitudinal axis perpendicular to the central axis and the lateralaxis. A method for preparing the prosthetic valve for delivery to apatient by a delivery catheter having a lumen with a lumen diameterincludes compressing the annular support frame vertically by reducingthe dimension of the annular support frame along the central axis fromthe expanded configuration to a dimension less than the lumen diameter.The annular support frame is compressed laterally by reducing thedimension of the annular support frame along the lateral axis from theexpanded configuration to a dimension less than the lumen diameter. Thecompressing of the annular support frame vertically and the compressingof the annular support frame laterally collectively disposing theannular support frame in a compressed configuration. The annular supportframe, when in the compressed configuration, is inserted into the lumenof the delivery catheter.

In some embodiments, a method of delivering a prosthetic valve to anannulus of a native valve between a ventricle and an atrium of a heartincludes disposing in the atrium of the heart a distal portion of adelivery catheter having a lumen and a longitudinal axis, with a distalend of the delivery catheter directed towards the annulus of the nativevalve. The prosthetic valve is disposed within the distal portion of thedelivery catheter in a compressed configuration. The prosthetic valvehas a tubular frame with a distal lower tension arm and a distal uppertension arm coupled to a distal sidewall thereof and a flow controlcomponent mounted within the tubular frame. The prosthetic valve has anexpanded configuration in which the flow control component permits bloodflow through the prosthetic valve in a first direction and blocks bloodflow through the prosthetic valve in a second direction, opposite thefirst direction. The prosthetic valve is disposed within the lumen ofthe delivery catheter with the distal lower tension arm and the distalupper tension arm disposed towards the distal end of the deliverycatheter. The method further includes releasing the distal lower tensionarm from the lumen of the delivery catheter and releasing the distalupper tension arm from the lumen of the delivery catheter. A portion ofthe distal lower tension arm is placed on the ventricle side of theannulus of the native valve while the distal upper tension arm remainson the atrium side of the annulus. After releasing the distal lowertension arm and releasing the distal upper tension arm, the remainder ofthe prosthetic valve is released from the lumen of the delivery catheterand the prosthetic valve is deployed into and secured to the annulus ofthe native valve while the distal upper tension arm is in contact withsupra-annular tissue on the atrium side of the annulus and the distallower tension arm is in contact with subannular tissue on the ventricleside of the annulus during the deploying.

The embodiments herein and the various features and advantageous detailsthereof are explained more fully with reference to the non-limitingembodiments that are illustrated in the accompanying drawings anddetailed in the following description. Descriptions of well-knowncomponents and processing techniques are omitted so as to notunnecessarily obscure the embodiments herein. The examples used hereinare intended merely to facilitate an understanding of ways in which theembodiments herein may be practiced and to further enable those of skillin the art to practice the embodiments herein. Accordingly, the examplesshould not be construed as limiting the scope of the embodiments herein.Rather, these embodiments are provided so that this disclosure will bethorough and complete, and will fully convey the scope of the inventiveconcepts to those skilled in the art. Like numbers refer to likeelements throughout.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to limit the full scope of theclaims. As used herein, the singular forms “a,” “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. With respect to the use of substantially any pluraland/or singular terms herein, those having skill in the art cantranslate from the plural to the singular and/or from the singular tothe plural as is appropriate to the context and/or application. Thevarious singular/plural permutations may be expressly set forth hereinfor sake of clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.).

It will be further understood that the terms “comprises” and/or“comprising,” when used in this specification, specify the presence ofstated features, integers, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, integers, steps, operations, elements, components,and/or groups thereof. As used in this document, the term “comprising”means “including, but not limited to.”

As used herein the term “and/or” includes any and all combinations ofone or more of the associated listed items.

It will be further understood by those within the art that virtually anydisjunctive word and/or phrase presenting two or more alternative terms,whether in the description, claims, or drawings, should be understood tocontemplate the possibilities of including one of the terms, either ofthe terms, or both terms. For example, the phrase “A or B” will beunderstood to include the possibilities of “A” or “B” or “A and B.”

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible subrangesand combinations of subranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal subparts. As will be understood by oneskilled in the art, a range includes each individual member.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art. Nothing in this disclosure is to be construed as anadmission that the embodiments described in this disclosure are notentitled to antedate such disclosure by virtue of prior invention.

The term “valve prosthesis” or “prosthetic valve” can refer to acombination of a frame and a leaflet or flow control structure orcomponent, and can encompass both complete replacement of an anatomicalpart (e.g., a new mechanical valve replaces a native valve), as well asmedical devices that take the place of and/or assist, repair, or improveexisting anatomical parts (e.g., the native valve is left in place).

The disclosed valves include a member (e.g., a frame) that can be seatedwithin a native valve annulus and can be used as a mounting element fora leaflet structure, a flow control component, or a flexiblereciprocating sleeve or sleeve-valve. It may or may not include such aleaflet structure or flow control component, depending on theembodiment. Such members can be referred to herein as an “annularsupport frame,” “tubular frame,” “wire frame,” “flange,” “collar,”and/or any other similar terms.

The term “flow control component” can refer in a non-limiting sense to aleaflet structure having 2-, 3-, 4-leaflets of flexible biocompatiblematerial such a treated or untreated pericardium that is sewn or joinedto a annular support frame, to function as a prosthetic heart valve.Such a valve can be a heart valve, such as a tricuspid, mitral, aortic,or pulmonary, that is open to blood flowing during diastole from atriumto ventricle, and that closes from systolic ventricular pressure appliedto the outer surface. Repeated opening and closing in sequence can bedescribed as “reciprocating.” The flow control component is contemplatedto include a wide variety of (bio)prosthetic artificial heart valves,including ball valves (e.g., Starr-Edwards), bileaflet valves (St.Jude), tilting disc valves (e.g., Bjork-Shiley), stented pericardiumheart-valve prosthesis' (bovine, porcine, ovine) (Edwards line ofbioprostheses, St. Jude prosthetic valves), as well as homograft andautograft valves. Bioprosthetic pericardial valves can includebioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetictricuspid valves, and bioprosthetic pulmonary valves.

In some embodiments, the frame and the flow control component can beseparate structures and delivered together or separately. The term“valve frame” or “prosthetic valve frame” or “valve-in-valve” can referto a three-dimensional structural component, usually tubular,cylindrical, or oval or ring-shaped, and that can be seated within anative valve annulus and used as a mounting element for a commerciallyavailable valve such as a Sapien, Sapien 3, or Sapien XT from EdwardsLifesciences, the Inspiris Resilia aortic valve from EdwardsLifesciences, the Masters HP 15 mm valve from Abbott, Lotus Edge valvefrom Boston Scientific, the Crown PRT leaflet structure fromLivanova/Sorin, the Carbomedics family of valves from Sorin, or otherflow control component, or a flexible reciprocating sleeve orsleeve-valve.

The term “expandable” as used herein may refer to a component of theheart valve capable of expanding from a first, delivery diameter to asecond, implantation diameter. An expandable structure, therefore, doesnot mean one that might undergo slight expansion from a rise intemperature, or other such incidental cause. Conversely,“non-expandable” should not be interpreted to mean completely rigid or adimensionally stable, as some slight expansion of conventional“non-expandable” heart valves, for example, may be observed.

The terms “side-delivered,” “side-delivery,” “orthogonal,” “orthogonallydelivered” and so forth are used to describe that the valves arecompressed and delivered at a roughly 90 degree angle compared totraditional transcatheter heart valves. Orthogonal delivery is atransverse delivery where a perimeter distal sidewall exits the deliverycatheter first, followed by the central aperture, followed by theproximal sidewall.

Mathematically, the term “orthogonal” refers to an intersecting angle of90 degrees between two lines or planes. As used herein, the term“substantially orthogonal” refers to an intersecting angle or 90 degreesplus or minus a suitable tolerance. For example, “substantiallyorthogonal” can refer to an intersecting angle ranging from 75 to 105degrees.

The disclosed valve embodiments may be delivered by a transcatheterapproach. The term “transcatheter” is used to define the process ofaccessing, controlling, and delivering a medical device or instrumentwithin the lumen of a catheter that is deployed into a heart chamber (orother desired location in the body), as well as an item that has beendelivered or controlled by such as process. Transcatheter access isknown to include via femoral artery and femoral vein, via brachialartery and vein, via carotid and jugular, via intercostal (rib) space,and via sub-xiphoid. Transcatheter can be synonymous with transluminaland is functionally related to the term “percutaneous” as it relates todelivery of heart valves.

In some of the disclosed embodiments, the prosthetic valve is secured inpart to native tissue by a tissue anchor. The term “tissue anchor” or“plication tissue anchor” or “secondary tissue anchor,” or “dart” or“pin” refers to a fastening device that connects the upper atrial frameto the native annular tissue, usually at or near the periphery of thecollar. The anchor may be positioned to avoid piercing tissue and justrely on the compressive force of the two plate-like collars on thecaptured tissue, or the anchor, itself or with an integrated securementwire, may pierce through native tissue to provide anchoring, or acombination of both. The anchor may have a specialized securementmechanism, such as a pointed tip with a groove and flanged shoulder thatis inserted or popped into a mated aperture or an array of matedapertures that allow the anchor to attach, but prevent detachment whenthe aperture periphery locks into the groove near the flanged shoulder.The securement wire may be attached or anchored to the collar oppositethe pin by any attachment or anchoring mechanisms, including a knot, asuture, a wire crimp, a wire lock having a cam mechanism, orcombinations.

Some disclosed embodiments include a support post. The term “supportpost” refers to a rigid or semi-rigid length of material such asNickel-Titanium alloy (Nitinol™) or polyetheretherketone (PEEK), thatmay be mounted on a spoked frame and that runs axially, or down thecenter of, or within a sewn seam of, the flexible sleeve. The sleeve maybe unattached to the support post, or the sleeve may be directly orindirectly attached to the support post.

The term “body channel” may be used to define a blood conduit or vesselwithin the body, the particular application of the disclosed embodimentsof prosthetic valves determines the body channel at issue. An aorticvalve replacement, for example, would be implanted in, or adjacent to,the aortic annulus. Likewise, a tricuspid or mitral valve replacementwould be implanted at the tricuspid or mitral annulus. Certain featuresare particularly advantageous for one implantation site or the other.However, unless the combination is structurally impossible, or excludedby claim language, any of the valve embodiments described herein couldbe implanted in any body channel.

As used herein, the term “lumen” can refer to the inside of a cylinderor tube. The term “bore” can refer to the inner diameter of the lumen.

In some embodiments, components may be fabricated from a syntheticmaterial such a polyurethane or polytetrafluoroethylene. Where a thin,durable synthetic material is contemplated, e.g., for a covering,synthetic polymer materials such expanded polytetrafluoroethylene (PTFE)or polyester may optionally be used. Other suitable materials mayoptionally include thermoplastic polycarbonate urethane, polyetherurethane, segmented polyether urethane, silicone polyether urethane,polyetheretherketone (PEEK), silicone-polycarbonate urethane,polypropylene, polyethylene, low-density polyethylene, high-densitypolyethylene, and ultra-high molecular weight polyethylene. Additionalbiocompatible polymers may optionally include elastomers, polyolefins,polyethylene-glycols, polyethersulphones, polysulphones,polyvinylpyrrolidones, polyvinylchlorides, other fluoropolymers,polyesters, polyethylene-terephthalate (PET) (e.g., Dacron),Poly-L-lactic acids (PLLA), polyglycolic acid (PGA), poly(D,L-lactide/glycolide) copolymer (PDLA), silicone polyesters, polyamides(Nylon), PTFE, elongated PTFE, expanded PTFE, polyurethanes, siloxanepolymers and/or oligomers, and/or polylactones, and block co-polymersusing the same.

The annular support frame is optionally internally or externallycovered, partially or completely, with a biocompatible material such aspericardium. The annular or tubular frame may also be optionallyexternally covered, partially or completely, with a second biocompatiblematerial such as polyester or Dacron®. Disclosed embodiments may usetissue, such as a biological tissue that is a chemically stabilizedpericardial tissue of an animal, such as a cow (bovine pericardium),sheep (ovine pericardium), pig (porcine pericardium), or horse (equinepericardium). Preferably, the tissue is bovine pericardial tissue.Examples of suitable tissue include that used in the productsDuraguard®, Peri-Guard®, and Vascu-Guard®, all products currently usedin surgical procedures, and which are marketed as being harvestedgenerally from cattle less than 30 months old. Other patents andpublications disclose the surgical use of harvested, biocompatibleanimal thin tissues suitable herein as biocompatible “jackets” orsleeves for implantable stents, including for example, U.S. Pat. No.5,554,185 to Block, U.S. Pat. No. 7,108,717 to Design &Performance-Cyprus Limited disclosing a covered stent assembly, U.S.Pat. No. 6,440,164 to Scimed Life Systems, Inc. disclosing abioprosthetic valve for implantation, and U.S. Pat. No. 5,336,616 toLifeCell Corporation discloses acellular collagen-based tissue matrixfor transplantation.

In some embodiments, frame components may include drug-eluting wireframes. Drug-eluting wire frames may consist of three parts: wire frameplatform, coating, and drug. Some of the examples for polymer-freecoated frames are Amazon Pax (MINVASYS) using Amazonia CroCo (L605)cobalt chromium (Co—Cr) wire frame with Paclitaxel as anantiproliferative agent and abluminal coating have been utilized as thecarrier of the drug. BioFreedom (Biosensors Inc.) using stainless steelas base with modified abluminal coating as carrier surface for theantiproliferative drug Biolimus A9. Optima (CID S.r.I.) using 316 Lstainless steel wire frame as base for the drug Tacrolimus and utilizingintegrated turbostratic carbofilm as the drug carrier. VESTA sync (MIVTherapeutics) using GenX stainless steel (316 L) as base utilizingmicroporous hydroxyapatite coating as carrier for the drug Sirolimus.YUKON choice (Translumina) used 316 L stainless steel as base for thedrugs Sirolimus in combination with Probucol.

Biosorbable polymers may also be used herein as a carrier matrix fordrugs. Cypher, Taxus, and Endeavour are the three basic type ofbioabsorbable DES. Cypher (J&J, Cordis) uses a 316 L stainless steelcoated with polyethylene vinyl acetate (PEVA) and poly-butylmethacrylate (PBMA) for carrying the drug Sirolimus. Taxus (BostonScientific) utilizes 316 L stainless steel wire frames coated withtranslute Styrene Isoprene Butadiene (SIBS) copolymer for carryingPaclitaxel, which elutes over a period of about 90 days. Endeavour(Medtronic) uses a cobalt chrome driver wire frame for carryingZotarolimus with phosphorylcholine as drug carrier. BioMatrix employingS-Wire frame (316 L) stainless steel as base with polylactic acidsurface for carrying the antiproliferative drug Biolimus. ELIXIR-DESprogram (Elixir Medical Corp) consisting both polyester and polylactidecoated wire frames for carrying the drug Novolimus with cobalt-chromium(Co—Cr) as base. JACTAX (Boston Scientific Corp.) utilized D-lacticpolylactic acid (DLPLA) coated (316 L) stainless steel wire frames forcarrying Paclitaxel. NEVO (Cordis Corporation, Johnson & Johnson) usedcobalt chromium (Co—Cr) wire frame coated with polylactic-co-glycolicacid (PLGA) for carrying the drug Sirolimus.

FIGS. 1A-1F are various schematic illustrations of a transcatheterprosthetic valve 102 according to an embodiment. The transcatheterprosthetic valve 102 is configured to deployed in a desired locationwithin a body (e.g., of a human patient) and to permit blood flow in afirst direction through an inflow end of the transcatheter prostheticvalve 102 and to block blood flow in a second direction, opposite thefirst direction, through an outflow end of the transcatheter prostheticvalve 102. For example, the transcatheter prosthetic valve 102 can be atranscatheter prosthetic heart valve configured to be deployed withinthe annulus of a native tricuspid valve or native mitral valve of ahuman heart to supplement and/or replace the functioning of the nativevalve.

The transcatheter prosthetic valve 102 (also referred to herein as“valve”) is compressible and expandable in at least one directionperpendicular to a long-axis 111 of the valve 102 (also referred toherein as “horizontal axis,” “longitudinal axis,” or “lengthwise axis”).The valve 102 is configured to compressible and expandable between anexpanded configuration (FIGS. 1A, 1B, 1C, and 1E) for implanting at adesired location in a body (e.g., a human heart) and a compressedconfiguration (FIGS. 1D and 1F) for introduction into the body using adelivery catheter (not shown).

In some embodiments, the valve 102 can be centric, or radiallysymmetrical. In other embodiments, the valve 102 can be eccentric, orradially (y-axis) asymmetrical. In some eccentric embodiments, the valve102 (or an outer frame thereof) may have a D-shape (viewed from the top)so the flat portion can be matched to the anatomy in which the valve 102will be deployed. For example, in some instances, the valve 102 may bedeployed in the tricuspid annulus and may have a complex shapedetermined by the anatomical structures where the valve 102 is beingmounted. In the tricuspid annulus, the circumference of the tricuspidvalve may be a rounded ellipse, the septal wall is known to besubstantially vertical, and the tricuspid is known to enlarge in diseasestates along the anterior-posterior line. In other instances, the valve102 may be deployed in the mitral annulus (e.g., near the anteriorleaflet) and may have a complex shape determined by the anatomicalstructures where the valve 102 is being mounted. For example, in themitral annulus, the circumference of the mitral valve may be a roundedellipse, the septal wall is known to be substantially vertical, and themitral is known to enlarge in disease states.

As shown, the valve 102 generally includes an annular support frame 110and a flow control component 150. In addition, the valve 102 and/or atleast the annular support frame 110 of the valve 102 optionally caninclude one or more of a distal upper tension arm 131, a distal lowertension arm 132, a proximal upper tension arm 133, a proximal lowertension arm 134, a guidewire collar 140, and/or an anchor deliveryconduit 145.

The annular support frame 110 (also referred to herein as “tubularframe,” “valve frame,” “wire frame,” or “fame”) can have or can definean aperture 114 that extends along a central axis 113. The aperture 114(e.g., a central axial lumen) can be sized and configured to receive theflow control component 150 across a diameter of the aperture 114. Theframe 110 may have an outer circumferential surface for engaging nativeannular tissue that may be tensioned against an inner aspect of thenative annulus to provide structural patency to a weakened nativeannular ring.

The frame 110 includes a cuff or collar 120 and a tubular section 112.The cuff or collar 120 (referred to herein as “cuff”) can be attached toand/or can form an upper edge of the frame 110. When the valve 102 isdeployed within a human heart, the cuff 120 can be an atrial cuff orcollar. The atrial collar 120 can be shaped to conform to the nativedeployment location. In a mitral replacement, for example, the atrialcollar 120 will be configured with varying portions to conform to thenative valve. In one embodiment, the collar 120 will have a distal andproximal upper collar portion. The distal collar portion can be largerthan the proximal upper collar portion to account for annular orsubannular geometries.

The frame 110 may optionally have a separate atrial collar attached tothe upper (atrial) edge of the frame 110, for deploying on the atrialfloor that is used to direct blood from the atrium into the flow controlcomponent 150 and to seal against blood leakage (perivalvular leakage)around the frame 110. The frame 110 may also optionally have a separateventricular collar attached to the lower (ventricular) edge of the frame110, for deploying in the ventricle immediately below the native annulusthat is used to prevent regurgitant leakage during systole, to preventdislodging of the valve 102 during systole, to sandwich or compress thenative annulus or adjacent tissue against the atrial collar or cuff 120,and/or optionally to attach to and support the flow control component150. Some embodiments may have both an atrial collar and a ventricularcollar, whereas other embodiments either include a single atrial collar,a single ventricular collar, or have no additional collar structure.

In some embodiments, the frame 110 can have an outer perimeter wallcircumscribing the aperture 114 and the central axis 113 in the expandedconfiguration. The perimeter wall can encompass both the collar 120 andthe tubular section 112. In some embodiments, the perimeter wall can befurther defined as having a front wall portion and a back wall portion,which are connected along a near side (e.g., relative to the inferiorvena cava (“IVC”)) or proximal side to a proximal fold area, andconnected along a far or distal side to a distal fold area. The frontwall portion can be further defined as having a front upper collarportion and a front lower body portion, and the back wall portion can befurther defined as having a back upper collar portion and a back lowerbody portion. The front upper collar portion and the back upper collarportion can collectively form the collar or cuff 120. The front lowerbody portion and the back lower body portion can collectively form thetubular section 112.

The frame 110 can be a ring, or cylindrical or conical tube, but mayalso have a side profile of a flat-cone shape, an inverted flat-coneshape (narrower at top, wider at bottom), a concave cylinder (walls bentin), a convex cylinder (walls bulging out), an angular hourglass, acurved, graduated hourglass, a ring or cylinder having a flared top,flared bottom, or both.

The frame 110 may have a height in the range of about 5-60 mm, may havean outer diameter dimension, R, in the range of about 20-80 mm, and mayhave an inner diameter dimension in the range of about 21-79 mm,accounting for the thickness of the frame 110 (e.g., a wire materialforming the frame 110).

The frame 110 design is preferably compressible and when released hasthe stated property that it returns to its original (uncompressed)shape. The frame 110 may be compressed for transcatheter delivery andmay be expandable using a transcatheter expansion balloon or as aself-expandable shape-memory element. In some instances, suitableshape-memory materials can include metals and plastics that are durableand biocompatible. For example, the frame 110 can be made from superelastic metal wire, such as a Nitinol wire or other similarlyfunctioning material. Nitinol can be desirable useful since it can beprocessed to be austenitic, martensitic or super elastic. Martensiticand super elastic alloys can be processed to demonstrate the desiredcompression. The material may be used for the frame 110 or any portionthereof. It is contemplated to use other shape memory alloys such asCu—Zn—Al—Ni alloys, Cu—Al—Ni alloys, as well as polymer compositesincluding composites containing carbon nanotubes, carbon fibers, metalfibers, glass fibers, and polymer fibers.

The frame 110 may be constructed as a braid, wire, or laser cut wireframe. Such materials are available from any number of commercialmanufacturers, such as Pulse Systems. One possible construction of thewire frame 110 envisions the laser cutting of a thin, isodiametricNitinol tube. The laser cuts form regular cutouts in the thin Nitinoltube. In one embodiment, the Nitinol tube is expanded to form athree-dimensional structure formed from diamond-shaped cells. Thestructure may also have additional functional elements, e.g., loops,anchors, etc. for attaching accessory components such as biocompatiblecovers, tissue anchors, releasable deployment and retrieval controlguides, knobs, attachments, rigging, and so forth. Secondarily the frame110 can be placed on a mold of the desired shape, heated to acorresponding martensitic temperature, and quenched. The treatment ofthe wire frame in this manner will form a frame 110 that has shapememory properties and will readily revert to the memory shape at thecalibrated temperature. Laser cut wire frames are preferably made fromNitinol, but also without limitation made from stainless steel, cobaltchromium, titanium, and other functionally equivalent metals and alloys.

Alternatively, the frame 110 can be constructed utilizing simplebraiding techniques. Using a Nitinol wire—for example, a 0.012″ wire—anda simple braiding fixture, the wire can be wound on the braiding fixturein a simple over/under braiding pattern until an isodiametric tube isformed from a single wire (e.g., the frame 110). The two loose ends ofthe wire are coupled using a stainless steel or Nitinol coupling tubeinto which the loose ends are placed and crimped. In some embodiments,angular braids of approximately 60 degrees can be desirable.Secondarily, the braided wire frame 110 is placed on a shaping fixtureand placed in a muffle furnace at a specified temperature to set thewire frame 110 to the desired shape and to develop the martensitic orsuper elastic properties desired.

Since the frame 110 is made of super elastic metal or alloy such asNitinol, the frame 110 is compressible. Preferably, the frame 110 isconstructed of a plurality of compressible wire cells having anorientation and cell geometry substantially orthogonal to the centralaxis 113 to minimize wire cell strain in the frame 110 when configuredin a vertical compressed configuration, a rolled compressedconfiguration, or a folded compressed configuration.

In a particular embodiment, the frame 110 (e.g., of a prosthetic heartvalve) may start in a roughly tubular configuration, and be heat-shapedto provide an upper atrial cuff or flange (e.g., the cuff 120) foratrial sealing and a lower trans-annular tubular or cylindrical sectionhaving an hourglass cross-section for about 60-80% of the circumferenceto conform to the native annulus along the posterior and anteriorannular segments while remaining substantially vertically flat along20-40% of the annular circumference to conform to the septal annularsegment.

The flow control component 150 can refer in a non-limiting sense to adevice for controlling fluid flow therethrough. In some embodiments, theflow control component 150 can be a leaflet structure having 2-, 3-,4-leaflets, or more, made of flexible biocompatible material such atreated or untreated pericardium. The leaflets can be sewn or joined toa support structure and/or can be sewn or joined to the frame 110. Theflow control component 150 can be mounted within the frame 110 andconfigured to permit blood flow in a first direction through an inflowend of the valve and block blood flow in a second direction, oppositethe first direction, through an outflow end of the valve. For example,the flow control component 150 can be configured such that the valve 102functions, for example, as a heart valve, such as a tricuspid valve,mitral valve, aortic valve, or pulmonary valve, that can open to bloodflowing during diastole from atrium to ventricle, and that can closefrom systolic ventricular pressure applied to the outer surface.Repeated opening and closing in sequence can be described as“reciprocating.” The flow control component 150 is contemplated toinclude a wide variety of (bio)prosthetic artificial valves, includingball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tiltingdisc valves (e.g., Bjork-Shiley), stented pericardium heart-valveprosthesis' (bovine, porcine, ovine) (Edwards line of bioprostheses, St.Jude prosthetic valves), as well as homograft and autograft valves.Bioprosthetic pericardial valves can include bioprosthetic aorticvalves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, andbioprosthetic pulmonary valves.

The arrangement of the valve 102 can be such that a commerciallyavailable valve (flow control component 150) can be received or acceptedby and/or otherwise mounted in the frame 110. Commercially availablevalves (flow control components 150) may include, for example, a Sapien,Sapien 3, or Sapien XT from Edwards Lifesciences, an Inspiris Resiliaaortic valve from Edwards Lifesciences, a Masters HP 15 mm valve fromAbbott, a Lotus Edge valve from Boston Scientific, a Crown PRT leafletstructure from Livanova/Sorin, a valve from the Carbomedics family ofvalves from Sorin, or other flow control component(s), or a flexiblereciprocating sleeve or sleeve-valve.

As described above, the valve 102 and/or at least the frame 110 of thevalve 102 can optionally include one or more of the distal upper tensionarm 131, the distal lower tension arm 132, the proximal upper tensionarm 133, the proximal lower tension arm 134, the guidewire collar 140,and/or the anchor delivery conduit 145. The tension arms 131, 132, 133,and 134 can be configured to engage a portion of the annular tissue tomount the frame 110 to the annulus of the native valve in which thevalve 102 is deployed. The tension arms 131, 132, 133, and/or 134 can beany suitable configuration such as those described below with respect tospecific embodiments. The anchor delivery conduit 145 can be attached tothe frame 110 and configured to receive a tissue anchor 190 (FIG. 1B)therethrough. The tissue anchor 190, in turn, can anchor the valve 102and/or at least the frame 110 to the annular tissue.

The valve 102 can be delivered to the desired location in the body via aprocedure generally including advancing a delivery catheter over a guidewire (not shown in FIGS. 1A-1F) to place a distal end of the deliverycatheter at or near the desired location. The guidewire, therefore, maybe disposed within the lumen of the delivery catheter. The valve 102 canbe disposed within the lumen of the delivery catheter (e.g., in thecompressed configuration) and advanced over the guidewire through thedelivery catheter. More particularly, in embodiments including theguidewire collar 140, the guidewire can extend through an aperture ofthe guidewire collar 140, thereby allowing the valve 102 to be advancedover or along the guidewire. The guidewire collar 140 can be attached tothe frame 110 and/or to at least one of the tension arms 131, 132, 133,and/or 134. The guidewire collar 140 can be configured to selectivelyengage a portion of the guidewire or a portion of a guidewire assemblyand/or can have any suitable configuration as described below withrespect to specific embodiments.

The valve 102 is compressible and expandable between the expandedconfiguration and the compressed configuration. The valve 102 is in theexpanded configuration when deployed or implanted (or ready to bedeployed or implanted) at the desired location in the body (e.g., theannulus of a native valve). The valve 102, when in the expandedconfiguration shown in FIG. 1C, has an extent in any direction along orlateral to the central axis 113 that is larger than a diameter of alumen of the delivery catheter used to deliver the valve 102 to thedesired location in the body. Said another way, the valve 102 has anextent in any direction perpendicular to the longitudinal axis of thevalve 111 that is larger than the diameter of the lumen of the deliverycatheter.

The valve 102 is in the compressed configuration when being delivered tothe desired location in the body via the delivery catheter. When in thecompressed configuration shown in FIG. 1D, the valve 102 can be disposedwithin the delivery catheter and can be compressed in a lateraldirection relative to the dimensions of the valve 102 in the expandedconfiguration and can be elongated in a longitudinal direction along thelongitudinal axis 111. The longitudinal axis 111 can be parallel to alongitudinal axis of the delivery catheter and can be oriented at anintersecting angle between 45 and 135 degrees relative to the centralaxis 113 (e.g., perpendicular or at about 90 degrees). In someembodiments, the horizontal x-axis (e.g., the longitudinal axis 111) ofthe valve 102 is orthogonal to (90 degrees), or substantially orthogonalto (75-105 degrees), or substantially oblique to (45-135 degrees) to thecentral vertical y-axis (e.g., the central axis 113) when in an expandedconfiguration. In some embodiments, the horizontal x-axis (e.g., thelongitudinal axis 111) of the valve 102 in the compressed configurationis substantially parallel to a lengthwise cylindrical axis of thedelivery catheter.

As used herein, the terms “intersecting angle” and/or “orthogonal angle”can refer to both (i) the relationship between the lengthwisecylindrical axis of the delivery catheter and the long-axis 111 of thecompressed valve 102, where the long-axis 111 is perpendicular to thecentral axis 113 of traditional valves, and (ii) the relationshipbetween the long-axis 111 of the compressed or expanded valve 102 andthe axis defined by the blood flow through the prosthetic valve 102where the blood is flowing, e.g., from one part of the body or chamberof the heart to another downstream part of the body or chamber of theheart, such as from an atrium to a ventricle through a native annulus.

As shown in FIGS. 1C and 1D, the valve 102 can have a first height orsize along the central axis 113 when in the expanded configuration andcan have a second height or size, less than the first height or size,along the central axis 113 when in the compressed configuration. Thesecond height or size of the valve 102 when in the compressedconfiguration is smaller than the diameter of the lumen of the deliverycatheter, allowing the valve 102 to be delivered therethrough.

The valve 102 can also be compressed in additional directions. Forexample, FIGS. 1E and 1F are top views of the valve 102 in the expandedconfiguration and the compressed configuration, respectively. The valve102 has a lateral axis 115 that is perpendicular to the longitudinalaxis 111 and the central axis 113. The valve 102, when in the expandedconfiguration, has an extent in any direction along or lateral to thelateral axis 115 that is larger than a diameter of the lumen of thedelivery catheter used to deliver the valve 102. In other words, thevalve 102 can have a first width or size along the lateral axis 115 whenin the expanded configuration shown in FIG. 1E and can have a secondwidth or size, less than the first width or size, along the lateral axis115 when in the compressed configuration shown in FIG. 1F.

The valve 102 may be compressed (as described above) and delivered in asideways or orthogonal manner such that the longitudinal axis 111 issubstantially parallel to a delivery axis (e.g., a lengthwise axis of adelivery catheter). The shape of the expanded valve 102 can be that of alarge diameter shortened cylinder with an extended collar or cuff (e.g.,the cuff 120). The valve 120 can be compressed, in some embodiments,where the central axis 113 of the valve 102 is roughly perpendicular to(orthogonal to) the lengthwise axis of the delivery catheter. In someembodiments, the valve 102 can be compressed vertically (e.g., along thecentral axis 113), similar to collapsing the height of a cylinderaccordion-style from taller to shorter. In addition, or as analternative, the valve 102 can be compressed laterally (e.g., along thelateral axis 115) similar to folding or compressing a front panelagainst a back panel. In other embodiments, the valve 102 can becompressed by rolling. In other embodiments, the valve 102 can becompressed using a combination of compressing, folding, and/or rolling.The compression along the central axis 113 (e.g., compression in avertical direction) and compression along the lateral axis 115 (e.g.,compression in a lateral or width-wise direction) is in contrast to thecompression of traditional co-axially delivered prosthetic valves, whichare generally compressed along the lateral axis (e.g., the lateral axis115) and the longitudinal axis (e.g., the longitudinal axis 111) andelongated along the central axis (e.g., the central axis 113).

In some embodiments, the valve 102 can have an expanded height (y-axis)of 5-60 mm. In some embodiments, the valve 102 can have an expandeddiameter length and width of 20-80 mm, preferably 40-80 mm, and incertain embodiments length and/or width may vary and include lengths of20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70mm, 75 mm, and 80 mm, in combination with widths that are the same ordifferent as the length.

In some embodiments, the valve 102 can have a compressed height (y-axis)and/or width (z-axis) of 6-15 mm, preferably 8-12 mm, and morepreferably 9-10 mm, and an expanded deployed height of about 5-60 mm,preferably about 5-30 mm, and more preferably about 5-20 mm or even 8-12mm or 8-10 mm. In some embodiments, the length of the valve 102 (x-axis)does not require compression since it can extend along the length of thecentral cylindrical axis of the delivery catheter when disposed therein.

In some embodiments, the valve 102 can be arranged such that an innerframe or structure of the flow control component 150 that holds, forexample, leaflet tissue is 25-29 mm in diameter, the frame 110 or aportion thereof is 50-70 mm in diameter, and the collar structure (cuff120) of the frame 110 extends beyond the top edge of the frame 110 by10-30 mm to provide a seal on the atrial floor against perivalvularleaks (PVLs).

Referring back to FIG. 1B, the valve 102 can be disposed within anannulus of a native valve in the human heart such as, for example, thepulmonary valve (PV) or the mitral valve (MV)—or the aortic valve ortricuspid valve, not shown in FIG. 1B). As described above, the valve102 can be in the compressed configuration and delivered to the annulusvia the delivery catheter. The valve 102 can be released from thedelivery catheter and allowed to expand to the expanded configurationshown in FIG. 1B. The deployment of the valve 102 can include placingthe distal lower tension arm 132 in the ventricle below the annuluswhile the remaining portions of the valve 102 is in the atrium. Thevalve 102 can be placed in the annulus of the native valve (PV or MV)and at least a portion of the distal lower tension arm 132 can bepositioned in an outflow tract of the ventricle (e.g., the RVOT, asshown in FIG. 1B). In embodiments in which the valve 102 includesadditional tension arms, the distal upper tension arm 131 and theproximal upper tension arm 133 can be disposed in the atrium above thenative valve and the proximal lower tension arm 134 can be disposed inthe ventricle below the native valve. As such, the one or more optionaltension arms 131, 132, 133, 134 included in the valve 102 can exert aforce on the native valve structure or tissue to mount the valve 102within the annulus of the native valve. For example, the upper tensionarms 131 and/or 133 can exert a supra-annular downward force in thedirection of the right ventricle and the lower tension arms 132 and/or134 can exert a sub-annular upward force in the direction of the rightatrium.

The mounting of the valve 102 in the annulus optionally can includeanchoring the valve 102 to the native valve via the tissue anchor 190.The tissue anchor 190 can be, for example, tines or barbs that arelocated to provide attachment to tissue adjacent the annulus. The tissueanchor 190 can be forced into the annular tissue by mechanical meanssuch as using a balloon catheter. In one non-limiting embodiment, thetissue anchor 190 may optionally be semi-circular hooks that uponexpansion of the frame 110 (or valve 102), pierce, rotate into, and holdannular tissue securely. The tissue anchors 190 can be deployed byover-wire delivery through a delivery catheter (e.g., via the anchordelivery conduit 145). The delivery catheter may have multiple axiallumens for delivery of a variety of anchoring tools, including anchorsetting tools, force application tools, hooks, snaring tools, cuttingtools, radio frequency and radiological visualization tools and markers,and suture/thread manipulation tools. Once the tissue anchor(s) 190 areattached to the valve, tensioning tools may be used to adjust the lengthof one or more tethers or the like that connect to the implanted valve102 to adjust and secure the implanted valve 102 as necessary for properfunctioning. It is also contemplated that the tissue anchor(s) 190 maybe spring-loaded and may have tether-attachment or tether-capturemechanisms built into the tethering face of the anchor(s) 190. Theanchors 190 or tether may pass through the anchor delivery conduit 145of the valve 102 or frame 110. The anchors 190 may also have in-growthmaterial, such as polyester fibers, to promote in-growth of the anchorsinto the heart tissue. In one embodiment, where the valve 102 may or maynot include a ventricular collar, the anchor 190 (e.g., a dart, tine, orbarb) is not attached to a lower ventricular collar but is attacheddirectly into annular tissue or other tissue useful for anchoring.

In some embodiments, the frame 110 and the flow control component 150can be separate structures and delivered to a desired location in thebody either together or separately. For example, the flow controlcomponent 150 can be positioned within the aperture 114 of the frame 110to form the complete valve 102, and the valve 102 can be compressed anddelivered to the desired location in the body via the delivery catheteras described in detail above. In other embodiments, the frame 110 andthe flow control component 150 can be delivered to the desired locationin the body separately. For example, the frame 110 can be compressed anddelivered to the desired location in the body via the delivery catheter.The frame 110 can be released from the delivery catheter and deployed,for example, in the annulus of the native valve. The frame 110 is in theexpanded configuration once released from the delivery catheter, andthus, is deployed in the annulus of the native valve in the expandedconfiguration. The flow control component 150 can then be deliveredseparately (e.g., via the delivery catheter) and mounted into thedeployed frame 110.

Provided below is a discussion of certain aspects or embodiments oftranscatheter prosthetic valves. The transcatheter prosthetic valves (oraspects or portions thereof) described below with respect to specificembodiments can be substantially similar in at least form and/orfunction to the valve 102 and/or corresponding aspects of the valve 102described above with reference to FIGS. 1A-1F. Thus, certain aspects ofthe specific embodiments are not described in further detail herein.

FIG. 2 is an illustration of a low profile, e.g., 8-20 mm, side-loadedprosthetic valve 1102 according to an embodiment. The valve 1102 can besubstantially similar to the valve 102 shown in FIGS. 1A-1F. FIG. 2shows the valve 1102 in an expanded configuration and deployed into thenative annulus.

FIG. 3 is an illustration of the valve 1102 having a frame 1110 and aflow control component 1150 shown compressed or housed within a deliverycatheter 1172.

FIG. 4A is an illustration of the valve 1102 shown ejected from thedelivery catheter 1172 and positioned against the anterior side of thenative annulus. While the valve 1102 is held at this oblique angle by asecondary catheter 1180, valve function and patient condition areassessed, (as described in more detail below) and if appropriate, thevalve is completely deployed within the native annulus, and anchoredusing traditional anchoring elements (e.g., such as the tissue anchor190).

FIG. 4B is an illustration of an open cross-section view of a lowprofile, side-loaded prosthetic valve 1202 according to an embodiment.The valve 1202 includes an inner valve sleeve or flow control component1250 and a frame 1210. The valve 1202 can be similar to the valve 1102.

FIG. 5 is an illustration of a low profile, side-loaded heart prostheticvalve 1302 according to an embodiment. The valve 1302 has a braid orlaser-cut construction for a tubular frame 1310, with a valve sleeve orflow control component 1350 that extends beyond the bottom of thetubular frame 1310. FIG. 5 shows a longer lower tension arm 1332 forextending sub-annularly towards the RVOT, and a shorter upper tensionarm 1331 for extending over the atrial floor.

FIG. 6 is an illustration of the valve 1302 being in a compressedconfiguration within a delivery catheter 1372. FIG. 6 shows the valve1302 attached to a secondary steerable catheter 1380 for ejecting,positioning, and anchoring the valve 1302. The secondary catheter 1380can also be used to retrieve a failed deployment of the valve 1302.

FIG. 7 is an illustration of the valve 1302 shown in a partiallycompressed configuration, partially within the delivery catheter 1372and partially ejected from the delivery catheter 1372. FIG. 7 shows thatwhile the valve 1302 is still compressed the lower tension arm 1332 canbe manipulated through the leaflets and chordae tendineae of the nativevalve to find a stable anterior-side lodgment for the distal side of thevalve 1302.

FIG. 8 is an illustration of the valve 1302 engaging the tissue on theanterior side of the annulus of a native valve with the curved distalsidewall of the tubular frame 1310 sealing around the native annulus.FIG. 8 shows the valve 1302 held by the steerable secondary catheter1380 at an oblique angle in which valve function can be assessed.

FIG. 9 is an illustration of valve 1302 fully deployed into the annulusof the native valve. The distal side of the valve 1350 is shown engagingthe tissue on the anterior side of the native annulus with the curveddistal sidewall of the tubular frame 1310 sealing around the nativeannulus, and with the proximal sidewall tension-mounted into theposterior side of the native annulus.

FIG. 10 is an illustration of a plan view of an embodiment of aprosthetic valve 1402 shown in a compressed configuration within adelivery catheter 1472. FIG. 10 shows a tubular frame 1410 rolled-over,outwardly, resulting in a 50% reduction in height of the catheter-housedvalve 1402. The low profile, side-loaded valve 1402 does not require theaggressive, strut-breaking, tissue-tearing, stitch-pulling forces thattraditional transcatheter valves are engineered to mitigate.

FIG. 11 is an illustration of a cross-sectional view of the compressedvalve 1402 within the delivery catheter 1472. This cross-sectional endview shows one embodiment of a single-fold compression configurationwhere the tubular frame 1402 and attached two-panel sleeve or flowcontrol component 1450 are rolled-over, outwardly, five times, resultingin a 50% reduction in height, and providing the ability to fit withinthe inner diameter of the 1 cm (10 mm) delivery catheter 1472.

FIG. 12 is an illustration of a cross-sectional view of anotherembodiment of the compressed valve 1402 folded within the deliverycatheter 1472. This cross-sectional end view shows another embodiment ofa single-fold compression configuration where the tubular frame 1410 andattached two-panel sleeve or flow control component 1450 arefolded-over, outwardly, four times, resulting in a 50% reduction inheight, and providing the ability to fit within the inner diameter ofthe 1 cm (10 mm) delivery catheter 1472.

FIG. 13 is an illustration of a cross-sectional view of the valve 1402to further illustrate how the folding and rolling configurations can beeffectuated due to the minimal material requirement of the low profile,side-loaded valve 1402.

FIG. 14A-14C illustrate a sequence of a low profile valve 1502 beingrolled into a compressed configuration for placement within a deliverycatheter 1572. The valve 1502 includes a tubular frame 1510 having anaperture 1514 and supporting a sleeve or flow control component 1550.

FIG. 15 is an illustration of an end view that shows the valve 1502having been longitudinally rolled and loaded within the deliverycatheter 1572 and shows the frame 1510 and sleeve flow control component1550.

FIGS. 16A to 16D illustrate one embodiment showing a four step processfor compressing a prosthetic valve 1602 to provide a long-axis (e.g.,similar to the long-axis 111 shown in FIGS. 1A-1F) that is co-planar orparallel with the lengthwise axis of a delivery catheter (not shown).These figures show that the valve 1602, having a tubular frame 1610 madeof a cuff and a trans-annular tubular section, having a flow controlcomponent 1610 mounted within the tubular frame 1610 and configured topermit blood flow in a first direction through an inflow end of thevalve and block blood flow in a second direction, opposite the firstdirection, through an outflow end of the valve 1602, is compressibleabout a long-axis that is parallel to a lengthwise axis of a deliverycatheter. These figures show that the valve 1602 is compressible to acompressed configuration for introduction into the body using a deliverycatheter where the compressed configuration has a long-axis that isperpendicular to the blood flow direction axis (e.g., oriented at anintersecting (orthogonal) angle of between 45-135 degrees (e.g., 90degrees) to the first (blood flow) direction), and where the long-axisof the compressed configuration of the valve 1602 is substantiallyparallel to a lengthwise axis of the delivery catheter, wherein thevalve 1602 has a height of about 5-60 mm and a diameter of about 25-80mm.

FIG. 16A shows an illustration of the valve 1602 in an uncompressedconfiguration. FIG. 16B shows an illustration of an initial rolling orfolding of the cuff of the frame 1610. The folding or rolling can beinwards as shown here, or may be outwardly rolled, or may also beflattened together for rolling the entire valve 1602 up from bottom totop. FIG. 16C shows an illustration of the valve 1602 that has beenrolled or folded, using multiple folds or rolls, along a long-axis intoa tube-shape. FIG. 16D shows an illustration of the completelycompressed valve 1602, that has been folded or rolled, e.g., using acompression accessory, into a compressed configuration, and which can bethen loaded into a delivery catheter (not shown). The compressed valve1602 may be self-expanding when released from the delivery catheterusing shape-memory alloys, or the valve 1602 may be balloon expanded ina secondary process once the valve 1602 is released from the deliverycatheter.

FIG. 17A is an illustration of a side perspective view of a sidedeliverable transcatheter prosthetic valve 1702 with at least one foldarea according to an embodiment, in an expanded configuration. FIG. 17Ashows a distal fold area 1723A in a collar portion 1720 of an annularframe 1710 that permits compression of the valve 1702 without subjectingthe annular frame 1710 or an inner flow control component 1750 todamaging compression forces.

FIG. 17B is an illustration of a side perspective view of the valve 1702showing an anterior side 1721 of the collar portion 1720 of the valve1702 commence a unilateral rolling process, indicated by the arrow 1763.FIG. 17B shows two fold areas, a proximal (near) fold area 1723A anddistal (far) area 1723B. The fold areas 1723A and 1723B may be devoid ofwire cells (wire frame portions) or may consist of cells that are largeor oriented to minimize the folding or rolling damage from thecompression process. Leaflets 1753 of the flow control component 1750are visible from this angle.

FIG. 17C is an illustration of a side perspective view of the valve 1702showing a second rolling step of the unilateral rolling process 1763.The anterior collar 1721 is rolled over to the central distal fold area1723B and the proximal fold area 1723A with a posterior-septal collar1722 in an unrolled expanded configuration.

FIG. 17D is an illustration of a side perspective view of the valve 1702showing a third rolling step of the unilateral rolling process 1763. Thevalve 1702 continues to be roll compressed towards the posterior-septalcollar 1722.

FIG. 17E is an illustration of a side perspective view of the valve 1702showing a completion of the unilateral rolling process 1763 to achieve acompressed configuration.

FIG. 18A is an illustration of a side perspective view of a valve 1802in an expanded configuration, showing two sides of the valve 1802commence a bilateral rolling process 1864, with two of four (shown) foldareas, distal fold area 1823B and second distal fold are 1824B. Ananterior collar 1821 of a frame 1810 of the valve 1802 and aposterior-septal collar 1822 of the frame 1810 are shown with outerframe wall 1816 and leaflets 1853 in dashed line for reference.

FIG. 18B is an illustration of a side perspective view of the valve 1802showing a second rolling step of the bilateral rolling process 1864. Arim of the annular support frame 1810 is shown rolling inward towards acentral axis 1811. The distal fold 1823B and the second distal fold 124Bare shown opposite from a proximal fold area 1823A and second proximalfold area 1824A, respectively. Flow control leaflets 1853 of a flowcontrol component 1850 of the valve 1802 are shown for reference.

FIG. 18C is an illustration of a side perspective view of the valve 1802showing a third rolling step of the bilateral rolling process 1864.Here, the rolled rim is further rolled inward towards the central axis1811.

FIG. 18D is an illustration of a side perspective view of the valve 1802showing a completion of the bilateral rolling compression process 1864shown rolled inward towards the central axis 1811. FIG. 18D shows thevalve 1802 as it would appear in a compressed configuration within adelivery catheter (not shown).

FIG. 19A is an illustration of a side perspective view of a valve 1902in a compressed configuration, that has been compressed using a rollingand folding process 1965. A lower portion of the valve 1902 is rolled,and an upper collar portion of the valve 1902 is folded lengthwisearound a central long-axis 1911.

FIG. 19B is an illustration of a side perspective view of the valve1902, partially uncompressed, showing unrolling of the lower bodyportion and unfolding of the flattened upper collar portion. FIG. 19Bshows fold areas 1923A and 1923B in the collar portion.

FIG. 19C is an illustration of a side perspective view of the valve1902, further uncompressed, showing the unrolled lower body portion andthe unfolded upper collar portion. The fold areas in the collar arewider as the valve 1902 assumes its expanded configuration.

FIG. 19D is an illustration of a side perspective view of the valve 1902in an expanded configuration, showing a different side/orientation,which is 90 degrees from the prior views.

FIG. 20 is an illustration of a side perspective view of a valve 2002having a circular hyperboloid (hourglass) shape. Wire frame details arenot shown since in practice the external surface would preferably becovered, such as with Dacron polyester to facilitate in-growth. Aproximal fold area 2023A and a distal fold area 2023B are shown onopposite ends of an anterior collar 2021 and a posterior-septal collar2022 of the frame 2010 along a horizontal axis 2011 with a frontanterior wall 2016 and central channel or aperture 2014 shown, accordingto an embodiment.

FIG. 21 is an illustration of a cut away view of the valve 2002. FIG. 21shows that inner leaflet 2053 and inner frame of the flow controlcomponent are attached to the inner surface of the annular frame 2010,with a collar portion 2020 attached to a subannular anchor portion 2032via a wall portion 2012. Here, the flow control component is onlyattached at a top edge of the frame 2010 although other non-limitingattachments are contemplated (e.g., mid-wall, multiple attachmentpoints, etc.).

FIG. 22 is an illustration of an exploded view of a valve or valve frame2110 according to an embodiment, having a funnel anterior collar 2121,funnel posterior-septal collar 2122, anterior cylinder body portion2112A, and posterior-septal cylinder body portion 2112B. FIG. 22 showsone variation where the valve frame 2110 includes wire cells used tocreate opposing panels, which are joined using fabric strain-minimizingpanels at a proximal fold area 2123A and a distal flow area 2123B. FIG.22 also shows a flow control component 2150 having a three-leaflet valve2153 mounted on an inner U-shaped wire frame 2152.

FIG. 23 is an illustration of a side view of the valve or valve frame2110 showing two (2) panels or walls 2116A and 2116B of the valve frame2110. The panel or wall 2116A can include the anterior collar portion2121 and the anterior cylinder body portion 2112A and the panel or wall2116B can include the posterior-septal collar portion 2122 and theposterior-septal cylinder body portion 2112B. FIG. 23 shows that diamondwire cells 2125A of the frame 2110 for the collar portion 2121 may beone large diamond in height, while the lower body portion 2112A may beconstructed using two smaller diamond wire cells in height. Dashed linesillustrate where the inner flow control component is attached but notshown.

FIG. 24 is an illustration of a side view of the two-panel embodiment ofthe valve or valve frame 2110 in a compressed configuration.

FIG. 25 is an illustration of an exploded view of a valve or valve frame2110 according to an embodiment, having a funnel anterior collar 2221,funnel posterior-septal collar 2222, anterior cylinder body portion2212A, and posterior-septal cylinder body portion 2212B. FIG. 25 showsone variation where the valve frame 2210 includes wire cells used tocreate the entire opposing panels. FIG. 25 also shows a flow controlcomponent 2250 having a three-leaflet valve 2253 mounted on an innerU-shaped wire frame 2252. FIG. 25 also shows a subannular tab 2230 thatcan be used for anchoring the frame 2210 in an annulus of a nativevalve.

FIG. 26 is an illustration of a side view of the valve or valve frame2210 showing two (2) panels or walls 2216A and 2216B of the valve frame2210. FIG. 26 shows that wave wire cells 2225B of the frame 2210 for thecollar portion 2221 may be one large wave cell in height, while thelower body portion 2212A may be constructed using one or two smallerwave wire cells in height. Dashed line illustrates where the inner flowcontrol component is attached but not shown.

FIG. 27 is an illustration of a side view of the two-panel embodiment ofthe valve or valve frame 2210 in a compressed configuration.

FIG. 28 is an illustration of a side perspective view of a frame 2310 ofa prosthetic valve formed by wave wire cells 2325B. The frame 2310 has aproximal folding area 2323A and a distal folding area 2323B in the wavewire cells 2325B. Dashed lines illustrate where an inner flow controlcomponent is attached but not shown.

FIG. 29 is an illustration of a top view of the valve frame 2310 showingthe proximal folding area or gap 2323A and the distal folding area orgap 2323B in the wave wire cells 2325B. A central flow control componentopening is shown as a horizontal linear gap 2354.

FIG. 30 is an illustration of a side perspective view of a frame 2410 ofa prosthetic valve formed by diamond wire cells 2425A. The frame 2310has a set of folding areas or gaps 2419 in the diamond wire cells 2425A.Dashed lines illustrate where an inner flow control component isattached but not shown. Wire frame details are not shown since inpractice the external surface would preferably be covered, such as withDacron polyester cover 2417 to facilitate in-growth.

FIG. 31 is an illustration of a top view of the valve showing thefolding areas or gaps 2419 in the generic annular support wire framehaving diamond wire cells 2425A. A central flow control componentopening is shown as a three-leaflet structure 2455.

FIG. 32A is an illustration of a side perspective view of a frame 2510of a prosthetic valve according to an embodiment. The frame 2510 has aset of folding areas or gaps 2519 in a generic wire cell structure wherethe folding gaps 2519 are covered with a fabric mesh spanning the gaps2519. Fabric folding panels 2519A are illustrated on the proximal anddistal sides of a lower body portion of the frame 2510. A polyestercover 2517 for the lower body portion of the frame 2510 is also shown.

FIG. 32B is an illustration of a side view of frame 2510 showing thelower body portion in a partially rolled configuration. FIG. 32B showsthat the lower body portion is unfurled towards the septal leaflet ofthe native valve.

FIG. 33A is an illustration of a side perspective view of a frame 2610of a prosthetic valve according to an embodiment. The valve 2610 has aflat collar portion 2620 and cylinder body portion 2612. FIG. 33A showsa proximal fold area 2623A and a distal fold area 2623B in the collarportion 2620 and a fold area 2626 in the lower body portion 2612 of theframe 2610.

FIG. 33B is an illustration of a side perspective view of the frame 2610shown flattened and partially compressed. FIG. 33B shows the two sidesof the collar slide 2620 inward, compressing the fold areas 2623A,2623B, to collapse the central axial opening or aperture, whileflattening the lower body portion 2612 along the fold area or seam 2626.

FIG. 33C is an illustration of a side perspective view of the frame 2610shown with the collar portion 2620 folded to be flattened and partiallycompressed and with the lower body portion 2612 rolled to be flattenedand partially compressed.

FIG. 33D is an illustration of a side perspective view of the frame 2610shown with the collar portion 2620 folded to be flattened and partiallycompressed and with the lower body portion 2612 being completelycompressed by rolling up to the collar portion 2620.

FIG. 33E is an illustration of a side perspective view of the flattened,compressed valve frame 2610 in its compressed configuration, with thelower body portion 2612 compressed by rolling and folded onto theflattened upper collar portion 2620.

FIG. 34A is an illustration of a side perspective view of a compositelaser-cut workpiece prior to expansion into a valve frame 2710. FIG. 34Ashows that a wire loop portion 2725C in combination with a wire mesh orwire braid portion 2725A can be combined in a single wire framestructure.

FIG. 34B is an illustration of a side perspective view of the valve 2710showing the composite laser-cut workpiece after expansion into the valvewireframe in an expanded configuration. FIG. 34B shows a collar portionof the frame 2710 having the braid or laser-cut wire cell structure2725B, and a lower body portion having the wire loop structure 2725C.

FIG. 35A is an illustration of a side perspective view of a laser-cutorthogonal cell workpiece prior to expansion into a set of valve framepanels or walls 2816A and 2816B. FIG. 35A illustrates asymmetricirregular rounded wire cells 2825D.

FIG. 35B is an illustration of a side perspective view of the laser-cutorthogonal workpiece after expansion into the valve wireframe panels orwalls 2816A and 2816B prior to assembly of the frame. FIG. 35B showsrounded, horizontally oriented wire cells 2825D for minimizing wirestrain during folding, rolling, and compression of the assembled frame.

FIG. 36A is an illustration of a side perspective view of a laser-cutorthogonal cell workpiece with zig-zag/diamond shape cells 2925A priorto expansion into a valve frame panels or walls 2916A and 2916B.

FIG. 36B is an illustration of a side perspective view of the laser-cutorthogonal workpiece with zig-zag/diamond shape cells 298 afterexpansion into the valve wireframe panels 280, 282, prior to assembly.FIG. 36B illustrates diamond-shaped, horizontally oriented wire cells298 for minimizing wire strain during folding, rolling and compression.

FIG. 37A is an illustration of a side perspective view of valvewireframe panels or walls 3016A and 3016B that are stitched along theside edges 3026A to form a three-dimensional valve frame 3010 having anarc-shape collar portion 3021, 3022 and a cylinder body portion with aninternal flow control component 3050 mounted within the cylinder bodyportion, and shown in a collapsed or folded configuration.

FIG. 37B is an illustration of a top perspective view of the valvewireframe panels or walls 3016A and 3016B that are stitched along theside edges 3026A to form the three-dimensional valve frame 3010 havingthe arc-shape collar portion 3021, 3022 and the cylinder body portionwith the internal flow control component 3050 mounted within thecylinder body portion, and shown in an expanded configuration.

FIG. 37C is an illustration of a side perspective view of the two-panelvalve frame 3010 being compressed by rolling. FIG. 37C shows two panels,sewn along the joining (stitched, joined) edges 3026.

FIG. 37D is an illustration of a side perspective view of the two-panelvalve frame 3010 in a rolled, compressed configuration with at least 1turn, and up to 1.5 turns—or at least 360 degrees, and up to at least540 degrees.

FIG. 38A is an illustration of a top view of a single sheet of metal ormetal alloy with compressible cells cut or formed into a first andsecond collar panel and a first and second body portion to form a wirevalve frame 3110. FIG. 38A shows a cut and fold design. FIG. 38A showswhere the collar can be folded so that the two points A on the collarare brought together, and the lower portion can be folded so that thetwo points B on the lower portion are brought together to form thethree-dimensional valve frame structure 3110 with partial folding tominimize the requirement for extensive sewing.

FIG. 38B is an illustration of a top perspective view of the singlesheet valve frame 3110 after folding, assembly, and attachment along theopen seams.

FIG. 38C is an illustration of a side perspective view of the singlesheet valve frame 3110 after folding, assembly, and attachment along theopen seams, in its expanded configuration.

FIG. 39 is an illustration of a side perspective view of a valve frame3210 formed from a series of horizontal wave-shaped wires 3225Econnected at connection points, with an upper collar portion, and anhourglass shape for the lower body portion, in its expandedconfiguration. Sewing features are shown along the joining edges.

FIG. 40 is an illustration of a side perspective view of a valve frame3310 formed from a series of (vertical) zigzag-shaped wires 3325Bconnected at connection points, with an upper collar portion, and anhourglass shape for the body portion, in its expanded configuration.Sewing features are shown along the joining edges.

FIG. 41A is an illustration of a top perspective view of a valve frame3410, in its expanded configuration, according to an embodiment. Thevalve frame 3410 has an upper collar portion formed from a series offan-shaped asymmetric, irregular rounded cells/wires 3425D connectedcircumferentially to the top peripheral edge of a lower body portion ofthe frame 3410.

FIG. 41B is an illustration of a cut away view of the valve frame 3410showing the upper collar portion formed from a series of fan-shapedasymmetric, irregular rounded cells/wires 3425D connectedcircumferentially to the top peripheral edge of the lower body portion,and showing half of a flow control component 3450 mounted with the lowerbody portion.

FIG. 41C is an illustration of a side perspective view of the upper cuffor collar portion of the frame 3410 in a partially expandedconfiguration, showing how the elongated fan-shape asymmetric, irregularrounded cells/wires 3425D permit elongation and radial compression.

FIG. 41D is an illustration of a side perspective view of a two-panelembodiment of the flow control component 3450.

FIG. 41E is an illustration of a side perspective view of an embodimentof the lower body portion of the frame 3410 having a braided wire cellconstruction 3425B.

FIG. 41F is an illustration of a side perspective view of an embodimentof the lower body portion of the frame 3410 having a diamond laser-cutwire cell construction 3425A.

FIG. 41G is an illustration of a side perspective view of an embodimentof a lower body portion of the frame 3410 having a connected-wave wirecell construction 3425E.

FIG. 42 is an illustration of a top view of flat wire frame of metal ormetal alloy having compressible wire cells configured in a strainminimizing orientation to facilitate orthogonal loading and delivery ofa prosthetic valve. The arrangement and/or formation of the compressiblewire cells allows the cells to compress, deform, or reconfigure when theprosthetic valve is compressed to the compressed configuration whileminimizing strain within the wire valve frame. FIG. 42 shows outer wavecells 3525B used for a collar portion of a wire frame with inner diamondcells 3525A used for a lower body portion of the wire frame.

FIG. 43 is an illustration of a top view of a smaller sized flat wireframe of metal or metal alloy having compressible wire cells configuredin a strain minimizing orientation to facilitate orthogonal loading anddelivery of a prosthetic valve. FIG. 43 shows outer wave cells 3525Bused for the collar portion of the wire frame with inner diamond cells3525A used for the lower body portion of the wire frame.

FIG. 44 is an illustration of a side perspective view of a portion of awire frame in a funnel configuration (heat set) showing compressiblewire cells configured in a strain minimizing orientation to facilitateorthogonal loading and delivery of a prosthetic tricuspid valve. FIG. 44shows outer diamond cells 3525A used for a collar portion of the wireframe and inner diamond cells 3525A used for the lower body portion ofthe wire frame.

FIG. 45 is an illustration of a side perspective view of a portion of awire frame in a funnel configuration (heat set) showing compressiblewire cells configured in a strain minimizing orientation to facilitateorthogonal loading and delivery of a prosthetic tricuspid valve. FIG. 45shows outer diamond cells 3525A used for a collar portion of the wireframe and inner diamond cells 3525A used for the lower body portion ofthe wire frame.

FIG. 46 is an illustration of a top view down the central axis of thewire frame in a funnel configuration (heat set) showing compressiblewire cells configured in a strain minimizing orientation to facilitateorthogonal loading and delivery of a prosthetic tricuspid valve. FIG. 46shows outer wave cells 3525B used for the collar portion of the wireframe and inner diamond cells 3525A used for the lower body portion ofthe wire frame.

One benefit of the two (or more) panel valve frame constructiondescribed in connection with several embodiments above is that eachframe panel can be formed as a flat sheet, rather than as a braid,laser-cut tube, etc. The manufacturing process for such flat sheetcomponents can be substantially less expensive than other techniques.For example, rather than using a laser to cut apertures in the sheet toform the wire frame structure, the sheet can be etched using, forexample, photolithography and resistive masks. This technique alsoenables the sheet to be selectively etched to different thicknesses indifferent areas of the sheet, providing more design control over themechanical or structural characteristics of different sections of thesheet (and thus of the valve frame formed from the sheet). FIG. 47A isan illustration of a side perspective view of a metal alloy sheet 3605Athat has been etched partially on a single side using photolithographyand resistive masks. The metal alloy sheet 3605A can be used to form awire valve frame.

FIG. 47B is an illustration of a side perspective view of a metal alloysheet 3605B that has been etched partially in a two-sided configurationusing photolithography and resistive masks. The metal alloy sheet 3605Bcan be used to form a wire valve frame.

As described above with reference to FIGS. 1A and 1B, a valve and/orvalve frame can include any number of tension arms and/or anchoringmembers configured to mount, secure, or anchor the valve and/or valveframe within the annulus of a native valve. The tension arms can, forexample, extend from the valve frame and can engage supra-annular tissueor subannular tissue. Tension arms included in the valve and/or valveframes described herein can be substantially similar in at least formand/or function to at least one of the tensions arms 131, 132, 133,and/or 134 described above with reference to FIGS. 1A and 1B. A valveand/or valve frame can include and/or can be coupled to an anchoringmember that can be used to mount or anchor the valve or valve frame inthe annulus of the native valve. Anchoring members included in and/orused with the valves and/or valve members described herein can besubstantially similar in at least form and/or function to the tissueanchor 190 described above with reference to FIGS. 1A and 1B.

FIG. 48 is an illustration of a plan view of an embodiment of aprosthetic valve with a valve frame 3710 having a distal upper tensionarm 3731 and a distal lower tension arm 3732 mounted on, and anchoredto, an anterior leaflet side of a native annulus. The frame 3710includes a mechanical anchor element such as, for example, a proximalsealing cuff 3720 for anchoring on the posterior-septal side of thenative annulus. The sealing cuff 3720 may be a short tab on theposterior side of the valve frame 3710 or may be a semi-circular orcircular collar or cuff (e.g., similar to the cuff 120 described abovewith reference to FIGS. 1A-1F) that engages the atrial floor to seal theannulus from perivalvular leaks. The deployment of the valve can includeplacing the valve frame 3710 at or near an annulus of a native valve andpositioning the distal lower tension arm 3732 in a subannular positionsuch as, for example, the RVOT. The distal upper tension arm 3731 can beplaced in a supra-annular position such as, for example, in the atriumof the heart. As such, the distal upper tension arm 3731 can exert asupra-annular downward force on the annular tissue and the distal lowertension arm 132 can exert an opposing subannular upward force on anopposite side of the annular tissue. The forces act to mount or securethe valve frame 3710 within the annulus of the native valve.

FIG. 49 is an illustration of a plan view of an embodiment of aprosthetic valve with a valve frame 3810 having a distal upper tensionarm 3831 and a distal lower tension arm 3832 mounted on, and anchoredto, the anterior leaflet side of the native annulus. The frame 3810includes a mechanical anchor element such as, for example, an hourglassannular seal 3820, for anchoring on the posterior-septal side of thenative annulus. The hourglass, or concave, sealing cuff 3820 may be onlya short segment on the posterior side of the valve or may be asemi-circular or circular combined upper and lower collar or cuff thatengages the atrial floor and the ventricular ceiling to seal the annulusfrom perivalvular leaks. The hourglass, or concave, sealing cuff 3820can be formed by, for example, a proximal upper tension arm 3833 and aproximal lower tension arm 3834. The proximal upper tension arm 3833 andthe proximal lower tension arm 3834 can exert opposing forces on theannular tissue as described with the distal tension arms 3831 and 3832.This embodiment may also include embodiments having a partial collar.This embodiment may be used in conjunction with other anchoring elementsdescribed herein such as a tissue anchor.

FIG. 50 is an illustration of a plan view of a prosthetic valve 3902according to an embodiment. The valve 3902 includes a valve frame 3910having a distal upper tension arm 3931 and a distal lower tension arm3932 mounted on and anchoring to the annulus. FIG. 50 shows distal lowertension arm 3932 extending into the RVOT. The lateral, or side-loaded,delivery of the valve 3902 through the inferior vena cava provides fordirect access to the native valve annulus without the need to deliver acompressed valve around a right angle turn, as is done for IVC deliveryof axially, or vertically loaded, traditional transcatheter prostheticvalves. FIG. 50 shows one embodiment where a tissue anchor 3990 such asa screw or other anchor device is used in conjunction with thetension-mounting method described herein where the distal upper andlower tension arms 3931 and 3932 on the anterior leaflet side anchor thevalve 3902 in place, and a secondary anchor element (e.g., the tissueanchor 3990) completes the securement of the valve 3902 in the annularsite.

FIG. 50 shows polyester mesh cover 3917 that covers the valve frame 3910and encircles a collapsible flow control sleeve of flow controlcomponent (not shown). FIG. 50 also shows the frame 3910 having Nitinolwire frame in diamond shape cells 3925A within or covered by thebiocompatible covering 3917. In one embodiment, the frame may have apericardial material on top and a polyester material, e.g., surgicalDacron, underneath to be in contact with the native annulus and promoteingrowth.

FIG. 51A is an illustration of a plan view of a low profile, e.g., 10 mmin height, prosthetic valve 4002 according to an embodiment, in anexpanded configuration. The valve 4002 includes a frame 4010 that hasand/or that forms a wire annulus support loop. The frame 4010 includesand/or forms (or the wire loop includes and/or forms) a distal uppertension arm 4031 and a distal lower tension arm 4032 that can be formedas a unitary or integral part and covered with a biocompatible material.This embodiment shows how the low profile, side-loaded valve 4002 canhaving a very large diameter, 40-80 mm, without having to deliver thevalve 4002 with an undesirably large delivery catheter, as would beotherwise used to deliver a large diameter valve that is delivered usingthe traditional, vertical or axial, orientation.

FIG. 51B is an illustration of a top view of the valve 4002 that showsthe inner two-panel sleeve or flow control component 4050 and thereciprocating collapsible aperture 4054 at the lower end for deliveringblood to the ventricle.

FIG. 51C is an illustration of a bottom-side view of the valve 4002 thatshows a plan view of the inner two-panel sleeve or flow controlcomponent 4050 and the collapsible terminal aperture 4054 at theventricular side.

FIG. 51D is an illustration of the valve 4002 in a compressedconfiguration and disposed within a delivery catheter 4072. FIG. 51Dillustrates how a large diameter valve 4002, using side loading, can bedelivered via the delivery catheter 4072.

FIG. 51E is an illustration of the valve 4002 in a compressedconfiguration being partially ejected, and partially disposed within,the delivery catheter 4072. FIG. 51E shows how the valve 4002 can bepartially delivered for positioning in the annulus. The distal lowertension arm 4034 can be used to navigate through the native tricuspidleaflets and chordae tendineae while the valve body, the tubular frame,4010 is still within the steerable delivery catheter 4072.

FIG. 52A is an illustration of a plan view of a prosthetic valve 4102partially mounted within a native valve annulus. By using theside-loaded valve 4102 of the disclosed embodiments, the distal uppertension arm 4133 and the distal lower tension arm 4132 can be mountedagainst an anterior aspect of the native annulus, and valve function canbe assessed before completely seating the valve 4102. By allowing twopathways for blood flow, the first through the native valve near theposterior leaflet, and the second through the central aperture of theprosthetic valve 4102, a practitioner can determine if the heart isdecompensating or if valve function is less than optimal. FIG. 52A alsoshows a proximal upper tension arm 4133 which can work in conjunctionwith the distal tension arms 4131 and 4132 to mount, seat, and/or anchorthe valve 4102 in the native annulus.

FIG. 52B is an illustration of a plan view of the prosthetic valve 4102completely seated within the valve annulus. FIG. 52B shows that thevalve 4102 can be secured in place once the valve function assessmentshows that the deployment is successful. Importantly, since the valve4102 is a low profile valve, and fits easily within a standard, e.g.,8-12 mm, delivery catheter without requiring the forceful loading oftypical transcatheter valves, the side-loading valve 4102 can be easilyretrieved using the same delivery catheter that is used to deploy thevalve.

FIG. 53A is an illustration of a prosthetic valve 4202 according to anembodiment in a compressed configuration within a delivery catheter4272. The valve 4202 includes a frame 4210 that has and/or that forms awire annulus support loop. The frame 4210 includes and/or forms (or thewire loop includes and/or forms) a distal upper tension arm 4231 and adistal lower tension arm 4232 that can be formed as a unitary orintegral part and covered with a biocompatible material. The lower andupper tension arms 4231 and 4232 are elongated to the right and theprosthetic valve 4202 is shown laterally compressed in the deliverycatheter 4272. The lateral compression is a function of the use ofminimal structural materials, e.g., a minimal inner valve sleeve of flowcontrol component 4250 (FIG. 53C), and the relatively short height ofthe frame 4210. This lateral delivery provides for a relatively large,e.g., up to 80 mm or more, prosthetic valve. The lateral delivery alsoavoids the need to perform a 90-degree right turn when delivering thevalve 4202 using the IVC femoral route. This sharp delivery angle whendelivering traditional valves has also limited the size and make up ofprior valve prostheses and the side-delivery of the valve 4202 avoidssuch limitations.

FIG. 53B is an illustration of a profile, or plan, view of thewire-frame 4210 of the valve 4202 in an expanded configuration. FIG. 53Bshows the distal upper tension arm 4231 is attached to the tubular frame4210 while the distal lower tension arm 4232 is shaped in an S-shape andis connected only to the distal upper tension arm 4231.

FIG. 53C is an illustration of a top view of the valve 4202 disposed ina native tricuspid valve. FIG. 53C shows the tubular frame 4210 and theinner sleeve or flow control component 4250 sewn into a central aperture4214 of the frame 4210, with the two (2) panels extending downward (intothe page) in a ventricular direction. FIG. 53C shows the distal uppertension arms 4231 oriented towards the anterior leaflet side of theatrial floor around the native tricuspid valve, which is shown in dashedoutline.

FIG. 53D is an illustration of a plan view and FIG. 53E is anillustration of a cut away plan view of the valve 4202. FIG. 53E showsthe inner panel valve sleeve or flow control component 4250 mountedwithin the inner space or aperture 4214 defined by the tubular frame4210. FIG. 53E shows an elongated two-panel valve sleeve or flow controlcomponent 4250 that extends into the sub-annular leaflet space. Thetubular frame 4210 shown in FIG. 53E is about 10 mm in height and thevalve sleeve or flow control component 4250 extends about 10 mm belowthe bottom of the tubular frame 4210, resulting in a valve 4202 having atotal height of 20 mm.

FIG. 53F is an illustration of a bottom view of the valve 4202 thatshows the tubular frame 4210 having an inner sleeve or flow controlcomponent 4250 sewn into the central aperture 4214, with the two panelsextending upward (out of the page) in a ventricular direction. FIG. 53Fshows the distal lower tension arm 4242 oriented towards the anteriorleaflet side of the ventricular ceiling of the native tricuspid valve,which is shown in dashed outline.

FIG. 54A is an illustration of a profile, or plan, view of a prostheticvalve 4302 according to an embodiment in an expanded configuration. Thevalve 4302 has a braid or laser-cut frame 4310. FIG. 54A shows a distalupper tension arm 4331 attached to an upper edge of the tubular frame4310, and a distal lower tension arm 4332 attached to a lower edge ofthe tubular frame 4310.

FIG. 54B is an illustration of a top view of the valve 4302 disposed ina native tricuspid valve. FIG. 54B shows the tubular frame 4310 havingan inner sleeve or flow control component 4350 sewn into a centralaperture of the frame 4310, with the two panels extending downward (intothe page) in a ventricular direction. FIG. 54B shows the distal uppertension arm 4331 oriented towards the anterior leaflet side of theatrial floor of the native tricuspid valve, which is shown in dashedoutline.

FIG. 54C is an illustration of a plan view and FIG. 54D is anillustration of a cut away plan view of the valve 4302. FIG. 54D showsthe inner panel valve sleeve or flow control component 4350 mountedwithin the inner space or central aperture defined by the tubular frame4310.

FIG. 54E is an illustration of a bottom view of the valve 4302 thatshows the tubular frame 4210 having the inner sleeve or flow controlcomponent 4350 sewn into the central aperture, with the two (2) panelsextending upward (out of the page) in a ventricular direction. FIG. 54Eshows the distal lower tension arm 4334 oriented towards the anteriorleaflet side of the ventricular ceiling, which is shown in dashedoutline.

FIG. 55A is an illustration of a side perspective view of a valve 4402according to an embodiment having a circular hyperboloid (hourglass)shape, in an expanded configuration. The valve 4402 includes a frame4410 having an extended RVOT tab 4430. The RVOT tab 4430 can be similarto the distal lower tension arms described herein. The wire framedetails are not shown since in practice the external surface wouldpreferably be covered, such as with Dacron polyester to facilitatein-growth. The frame 4410 includes a proximal fold area 4423A and adistal fold area 4423B that are shown on opposite ends of an anteriorcollar 4421 and posterior-septal collar 4422 along a horizontallong-axis 4411. The frame 4410 defines a central channel or aperturethat accepts a flow control component.

FIG. 55B is an illustration of a cut away view of the valve 4402 showingcircular hyperboloid (hourglass) shape thereof and the RVOT tab 4430(e.g., the distal lower tension arm). FIG. 55B shows that an innerleaflet 4453 and flow control component inner frame (not visible) areattached to an inner surface of the annular frame 4410, with collarportion 4420 attached to the RVOT tab or subannular anchor portion 4430via a wall portion 4412. Here, the flow control component is onlyattached at the top edge although other non-limiting attachments arecontemplated, e.g., mid-wall, multiple attachment points, etc.

FIG. 56A is an illustration of a side view of a vertically compressiblevalve 4502 with an internal non-extending set of leaflets (e.g., a flowcontrol component) and compressible orthogonal (wide) wire cells andshown in an expanded configuration for implanting in a desired locationin the body.

FIG. 56B is an illustration of a side view of the verticallycompressible valve 4502 shown in a compressed configuration for deliveryof the compressed valve 4502 to the desired location in the body.

FIG. 57A is an illustration of a side view of a vertically compressiblevalve 4602 with extended leaflets 4653 (e.g., a flow control component)and compressible orthogonal (wide) wire cells and shown in an expandedconfiguration for implanting in a desired location in the body.

FIG. 57B is an illustration of a side view of the verticallycompressible valve 4602 shown in a compressed configuration for deliveryof the compressed valve 4602, where the wire frame is reduced in height(vertically compressed) and the extended leaflets are rolled up.

FIGS. 58A and 58B are illustrations of a side perspective view and a topview, respectively, of a valve 4702 having a wire frame 4710 that isformed from a single continuous wire, with an upper collar portion, alower body portion having an hourglass shape, and a RVOT tab or distallower tension arm extending away from the lower edge of the lower bodyportion of the frame 4710. The valve 4702 is shown in an expandedconfiguration.

FIG. 59 is an illustration of a side perspective view of a valve frame4810 formed from a series of wave-shaped wires 4825E connected atconnection points, with an upper collar portion, a lower body portionhaving an hourglass shape, and an RVOT tab or distal lower tension armextending away from a lower edge of the lower body portion of the frame4810. The valve frame 4810 is shown in an expanded configuration. Sewingfeatures are shown along the joining edges.

FIG. 60 is an illustration of a side perspective view of a valve frame4910 formed from a series of horizontal wave-shaped wires 4925Fconnected at connection points, with an upper collar portion, a lowerbody portion having an hourglass shape, and an RVOT tab or distal lowertension arm extending away from a lower edge of the lower body portionof the frame 4910. The valve frame 4910 is shown in an expandedconfiguration. Sewing features are shown along the joining edges.

FIG. 61 is an illustration of a top view of flat wire frame of metal ormetal alloy having compressible wire cells configured in a strainminimizing orientation to facilitate orthogonal loading and delivery ofa prosthetic tricuspid valve. FIG. 61 shows outer diamond cells 5025Aused for a collar portion 5025B of a wire frame with inner wave cells5025B used for a lower body portion of the wire frame, and diamond cells5025A used for a subannular tab 5030 (e.g., a distal lower tension arm).

FIG. 62 is an illustration of a top view of a portion of a wire frame ina funnel configuration (heat set) showing compressible wire cellsconfigured in a strain minimizing orientation to facilitate orthogonalloading and delivery of a prosthetic tricuspid valve. FIG. 62 showsouter diamond cells 5025A used for a collar portion of the wire frameand inner diamond cells 5025A used for a lower body portion of the wireframe and a subannular tab 5030 (e.g., a distal lower tension arm).

FIG. 63 is an illustration of a side view of a portion of a wire framein a funnel configuration (heat set) showing compressible wire cellsconfigured in a strain minimizing orientation to facilitate orthogonalloading and delivery of a prosthetic tricuspid valve. FIG. 63 showsouter diamond cells 5025A used for a collar portion of the wire frameand inner diamond cells 5025A used for a lower body portion of the wireframe and a subannular tab 5030 (e.g., a distal lower tension arm).

FIG. 64 is an illustration of a side perspective view of a portion of awire frame in a funnel configuration (heat set) showing compressiblewire cells configured in a strain minimizing orientation to facilitateorthogonal loading and delivery of a prosthetic tricuspid valve. FIG. 64shows outer diamond cells 5025A used for a collar portion of the wireframe and inner diamond cells 5025A used for a lower body portion of thewire frame, and irregular shaped cells used for a subannular tab 5030(e.g., a distal lower tension arm).

FIG. 65A is an illustration of a top view of a prosthetic valve 5102according to an embodiment having braid or laser-cut wire frame 5110 andshown mounted within a cross-sectional view of the atrial floor at theannulus of a native tricuspid valve.

FIG. 65B is an illustration of a bottom view of the valve 5102 havingthe braid or laser-cut wire frame 5110 that includes and/or forms adistal lower tension arm 5132 and shown mounted within a cross-sectionalview of the ventricular ceiling at the annulus of a native tricuspidvalve. FIG. 65B shows a two-panel valve sleeve or flow control component5150 in an open position and disposed within a central aperture 5114 ofthe frame 5110. The flow control component 5150 can be in the openposition, for example, for atrial systole and ventricular diastole.

FIG. 66 is an illustration of a prosthetic valve 5202 according to anembodiment, in an expanded configuration. The valve 5202 includes aframe 5210 that has and/or that forms a wire annulus support loop, withtwo vertical support posts 5252 extending down the edge on opposingsides of an inner sleeve or flow control component 5250. Duringcompression into a delivery catheter, the posts 5252 are engineered tofold horizontally, and to elastically unfold during ejection to deploythe valve sleeve or flow control component 5252. FIG. 66 also shows theframe 5210 with a distal upper tension arm 5231 and a distal lowertension arm 5232 that can be formed as a unitary or integral part andcovered with a biocompatible material. FIG. 66 also illustrates aproximal tab 5230 that can be, for example, a tension arm and/or ananchoring post or point.

FIG. 67 is an illustration of a two-panel embodiment of an inner valvesleeve or flow control component 5350. In some embodiments, the frame5210 shown in FIG. 66 can be adapted to receive the flow controlcomponent 5350.

FIGS. 68A and 68B are illustrations of a side perspective view and a cutaway plan view, respectively, of a flow control component 5450 havingtwo rigid support posts 5452. FIG. 68B shows the flow control component5450 having the two rigid support posts 5452 mounted within the innerspace or central aperture define by a tubular frame 5410, where theframe 5410 includes a distal upper tension arm 5431 and a distal lowertension arm 5432 extending away from the frame 5410.

FIG. 69 is an illustration of a three-panel embodiment of an inner valvesleeve of flow control component 5550 according to an embodiment.

FIG. 70A is an illustration of a three-panel embodiment of an innervalve sleeve or flow control component 5550 having three rigid supportposts 5552 according to an embodiment.

FIG. 70B is an illustration of a cut away plan view of the three panel,three post valve sleeve or flow control component 5550 mounted withinthe inner space or central aperture defined by a tubular frame 5510,where the frame 5510 includes a distal upper tension arm 5531 and adistal lower tension arm 5532 extending away from the frame 5510.

FIG. 71A is an illustration of one embodiment of a partial cut-awayinterior view of a tri-leaflet embodiment of a low profile, e.g., 8-20mm, side-loaded prosthetic valve 5702 having a frame 5710 and a flowcontrol component 5750. The frame 5710 includes a distal lower tensionarm 5732. The flow control component 5750 is a tri-leaflet flow controlcomponent with three rigid support posts 5752.

FIG. 71B is an illustration of another embodiment of a partial cut-awayinterior view of the tri-leaflet embodiment of the low profile, e.g.,8-20 mm, side-loaded prosthetic valve 5702 showing the flow controlcomponent 5750 in a non-cut-away view.

FIG. 71C is an illustration of a top view of the tri-leaflet embodimentof the low profile, e.g., 8-20 mm, side-loaded prosthetic valve 5702.

FIGS. 72A-72C are various schematic illustrations of a delivery system270 for delivering a transcatheter prosthetic valve 202 according to anembodiment. The transcatheter prosthetic valve 202 is configured todeployed in a desired location within a body (e.g., of a human patient)and to permit blood flow in a first direction through an inflow end ofthe transcatheter prosthetic valve 202 and to block blood flow in asecond direction, opposite the first direction, through an outflow endof the transcatheter prosthetic valve 202. For example, thetranscatheter prosthetic valve 202 can be a transcatheter prostheticheart valve configured to be deployed within the annulus of a nativetricuspid valve or native mitral valve of a human heart to supplementand/or replace the functioning of the native valve.

The transcatheter prosthetic valve 202 is compressible and expandable inat least one direction perpendicular to a long-axis of the valve 202.The valve 202 is configured to compressible and expandable between anexpanded configuration for implanting at a desired location in a body(e.g., a human heart) and a compressed configuration for introductioninto the body via the delivery system 270.

In some embodiments, the prosthetic valve 202 can be similar to orsubstantially the same as the valve 102 described above with referenceto FIGS. 1A-1F. For example, FIG. 72B shows that the valve 202 caninclude an annular support frame 210 and a flow control component 250.The annular support frame 210 can be similar to the frame 110 and caninclude a cuff or collar portion 220 and a tubular section (e.g., alower tubular body portion) 212, and a guidewire collar 240. Inaddition, the annular support frame 210 defines an aperture 214 thatextends along or in the direction of a central axis 213 of the frame210. While not shown, the frame 210 and/or the valve 202 can alsoinclude one or more tension arms, anchoring tabs, and/or the like. Theflow control component 250 can be similar to the flow control component150 described above with reference to FIGS. 1A-1F. The valve 202 beingsubstantially similar to the valve 102, is not described in furtherdetail herein.

As shown in FIGS. 72A-72C, the delivery system 270 includes a deliverycatheter 272, a secondary catheter 280, and a guidewire 285. Thedelivery system 270 can be configured to orthogonally deliver thecompressed valve 202 and/or portions of the valve 202 (e.g., thecompressed frame 210 or the compressed flow control component 250) to adesired location in the body such as, for example, the annulus of anative tricuspid valve and/or the annulus of a native mitral valve ofthe human heart. As described in detail above with reference to thevalve 102, the delivery system 270 can orthogonally deliver the valve202, which has been compressed to the compressed configuration by beingcompressed along the central axis 213 (FIG. 72B) or compressed in alateral direction (e.g., orthogonal to the central axis 213 and acentral lengthwise axis 275 of the delivery catheter 272). Suchcompression can result in elongation of the valve 202 along alongitudinal axis (not shown in FIGS. 72A-72C), which is substantiallyparallel to the central lengthwise axis 275 of the delivery catheter272.

The delivery catheter 272 defines a lumen 274 that extends along or inthe direction of the central lengthwise axis 275. The lumen 274 of thedelivery catheter 272 can have a diameter sufficient to receive thecompressed valve 202 therethrough. For example, the delivery catheter272 can be 22-34 Fr, with any suitable corresponding internal lumendiameter and/or an internal lumen diameter sufficient to receive theprosthetic valve 202 in the compressed configuration.

The guidewire 285 extends or threads through the secondary catheter 280,the valve 202, and the delivery catheter 272. The guidewire 285 can be,for example, a sheathed guidewire at least partially sheathed by thesecondary catheter 280. The guidewire 285 is configured to be advancedthrough the anatomy of the body and placed in a desired positionrelative to native tissue (e.g., a native valve). In some instances, theguidewire 285 can be advanced to provide a wire path (e.g., for thedelivery catheter 272, the valve 202, etc.) to the RVOT. The guidewire285 extends through the guidewire collar 240 of the valve 202 to providea wire path along which the valve 202 is advanced.

The secondary catheter 280 can be a sheath, tube, annular rod or wire,and/or the like. In some embodiments, the secondary catheter 280 is ahypotube sheath disposed about a portion of the guidewire 285 (e.g., thesecondary catheter 280 and the guidewire 285 collectively form asheathed guidewire or sheathed guidewire assembly). The secondarycatheter 280 can have a relatively small size allowing the secondarycatheter 280 to be advanced through the delivery catheter 272 and/or atleast partially disposed in or otherwise engaged with the guidewirecollar 240. As shown in FIGS. 72A-72C, the secondary catheter 280 has alumen with an internal diameter that is greater than the guidewire 285,allowing the guidewire 285 to pass therethrough.

The pusher 281 is disposed within the secondary catheter 280 and isconfigured to push on a portion of the valve 202 to advance the valve202 through and/or out of the delivery catheter 272. In someimplementations, the pusher 281 is configured to push against a portionof the guidewire collar 240 of the valve 202. For example, the guidewirecollar 240 can allow the guidewire 285 to be advanced through theguidewire collar 240 and can block and/or substantially prevent thepusher 281 from being advanced beyond the guidewire collar 240 (or atleast a portion thereof). While the pusher 281 is shown disposed in thesecondary catheter 280, in some embodiments, the secondary catheter 280can be used as the pusher 281. In such embodiments, the delivery system270 need not include a separate pusher 281.

The guidewire collar 240 of the valve (FIG. 72B) can be any suitableelement that selectively allows the guidewire 285 to be advancedtherethrough while blocking or preventing the advancement of thesecondary catheter 280 and/or the pusher 281 beyond the guidewire collar240. In some embodiments, the guidewire collar 240 can be included in,formed by, and/or attached to the cuff 220 of the frame 210. In someembodiments, guidewire collar 240 can be included in, formed by, and/orattached to a tension arm such as, for example, a distal upper tensionarm, a distal lower tension arm, and/or the like. In certainembodiments, the distal lower tension arm can form and/or can include afeature that forms the guidewire collar 240. It may be desirable toattach the guidewire collar 240 to the distal lower tension arm sinceboth the guidewire 285 and the distal lower tension arm are insertedinto or directed toward the RVOT.

In some embodiments, the guidewire collar 240 can be a ball or featureof a tension arm that defines an aperture or lumen that is sufficientlylarge to allow the guidewire 285 to pass through but is not sufficientlylarge to allow the secondary catheter 280 and/or the pusher 281 to beadvanced therethrough. As such, the secondary catheter 280 and/or thepusher 281 can be stopped against the guidewire collar 240 by the largercircumference of the secondary catheter 280 and/or pusher 281 relativeto the aperture or lumen of the guidewire collar 240. Such anarrangement allows the secondary catheter 280 and/or pusher 281 to pushon the guidewire collar 240 and thus, the tension arm (e.g., the distallower tension arm) to which it is attached. When the guidewire collar240 is attached to a distal tension arm, the pushing on the guidewirecollar 240 is operative to pull the valve 202 through and/or out of thedelivery catheter 272. It is contemplated that the guidewire collar 240can have any suitable configuration that allows the guidewire collar 240to permit the advancement of the guidewire 285 while limiting, blocking,or preventing advancement of the secondary catheter 280 and/or thepusher 281. Moreover, the release mechanism 282 can be configured torelease the guidewire 285, the secondary catheter 280 and/or the pusher281 from the guidewire collar 240, for example, after deployment of thevalve 202.

FIG. 72C shows the delivery system 270 delivering the valve 202 to anative valve such as a mitral valve or pulmonary valve (or tricuspidvalve or aortic valve). The guidewire 285 is advanced to through theannulus of the native valve and disposed within the ventricle (e.g.,within the RVOT). The delivery catheter 272 can be advanced over theguidewire 285 and delivered to the desired location at or near theannulus. Once the delivery catheter 272 is in the desired location, thevalve 202 can be advanced over the guidewire 285 and within the deliverycatheter 272 by pushing on the secondary catheter 280 and/or pusher 281.When the guidewire collar 240 is attached to a distal or anterior sideof the valve 202 or frame 210, the pushing of the secondary catheter 280and/or pusher 281 acts like a pulling force relative to, for example,the tubular section 212 of the valve frame 210 and/or the flow controlcomponent 250 of the valve 202. Moreover, the secondary catheter 280and/or the pusher 281 can be used to eject the valve 202 from thedelivery catheter 272. Once ejected from the delivery catheter 272, thevalve 202 is allowed to expand to the expanded configuration and can beseated within the annulus of the native valve. In some embodiments,secondary catheter 280, the pusher 281, and/or the guidewire 285 can bereleased from the guidewire collar 240 to allow the secondary catheter280, the pusher 281, and/or the guidewire 285 to be retracted and/orwithdrawn. In some embodiments, the secondary catheter 280 and/or thepusher 281 can be used to push at least a proximal side of the valve 202or valve frame 210 into the annulus, thereby completely seating and/ordeploying the valve 202. Although not shown in FIGS. 72A-72C, in someembodiments the secondary catheter 280 and/or pusher 281 can be furtherused to deliver and/or anchor a tissue anchor to the proximal side ofthe valve 202 or valve frame 210. Thus, the delivery system 270 candeliver a traditionally compressed valve or orthogonally deliververtically and/or laterally compressed valve 202.

FIG. 72D is a flowchart describing a method 300 for delivering a lowprofile, side-loaded prosthetic valve such as any of the valvesdisclosed herein, according to an embodiment. The method 300 includesdisposing in an atrium of the heart, a distal portion of a deliverycatheter containing a frame of a prosthetic valve in a compressedconfiguration, directed towards the annulus of a native valve of theheart, at 302. The valve can be any of the valves disclosed herein. Forexample, the valve can be similar in at least form and/or function tothe valves 102 and/or 202 described above. In some embodiments, thevalve can be a valve (i) where the valve has a tubular frame with a flowcontrol component mounted within the tubular frame, (ii) where the valveor flow control component is configured to permit blood flow in a firstdirection through an inflow end of the valve and to block blood flow ina second direction, opposite the first direction, through an outflow endof the valve, (iii) where the valve is compressible and expandable andhas a long-axis oriented at an intersecting angle of between 45-135degrees to the first direction, and (iv) where the long-axis is parallelto a length-wise cylindrical axis of a delivery catheter used to deliverthe valve.

A tension arm of the prosthetic valve frame is released from thedelivery catheter, 304. The tension arm can be, for example, a distallower tension arm of the valve frame. The arrangement of the valvewithin the delivery catheter can be such that the distal lower tensionarm is distal to the valve body. In other words, the compressed valve isdisposed within the delivery catheter such that a long-axis (alongitudinal axis) is substantially parallel to a long-axis orlength-wise axis of the delivery catheter with the distal lower tensionarm extending in a distal direction from the valve body. Thus, thedistal lower tension arm is generally released from the deliverycatheter prior to the valve body.

A distal portion of the tension arm is disposed on the ventricle side ofthe annulus of the native valve while the distal end of the deliverycatheter remains on the atrium side of the annulus, at 306. The tensionarm (e.g., the distal lower tension arm) can extend through the nativeannulus and at least partially disposed within the RVOT. In someinstances, the tension arm can engage sub-annular tissue to at leastpartially secure the distal end portion of the valve to the nativeannular tissue while the remainder of the valve is maintained in asupra-annular position within the atrium side of the annulus.

The remainder of the prosthetic valve frame is released from thedelivery catheter, at 308. As described in detail above with respect tospecific embodiments, releasing the remainder of the prosthetic valveallows the prosthetic valve to expanded from the compressedconfiguration within the delivery catheter to the expanded configurationoutside of the delivery catheter and suitable for deployment into thenative annulus.

The method 300 optionally may include holding the prosthetic valve frameat an angle relative to the native valve annulus, at 310. The angle canbe, for example, an oblique angle relative to the native valve annulus.In some embodiments, a delivery system or the like can include asecondary catheter or push/pull rod that can be used to (1) advance thevalve through the delivery catheter and (2) temporarily hold theprosthetic valve at the angle relative to the native valve annulus. Ifthe prosthetic valve is held at the angle, blood may be allowed to flowfrom the atrium to the ventricle partially through the native valveannulus around the prosthetic valve frame, and partially through theprosthetic valve, at 312. The blood flow may be used to optionallyassess valve function, at 314. If the prosthetic valve does not appearto be functioning properly, the valve can be replaced without having toremove a fully deployed valve.

Dispose the tubular portion of the frame within the annulus of thenative valve, at 316. For example, in some embodiments, the secondarycatheter or push/pull rod can be used to push at least the proximal endportion of the valve into the native annulus. In some implementations,one or more walls of the valve and/or one or more proximal or distaltension arms can be used to seat the prosthetic valve within the nativeannulus. For example, the tension arms can exert opposing forces thatcan at least partially secure the prosthetic valve to the annulartissue. In some embodiments, the tension arms and/or any other portionof the frame can form a rotational or pressure lock against the annulartissue. With the tubular portion of the frame within the annulus of thenative valve, the prosthetic valve can be fully deployed.

The method 300 optionally may include anchoring the proximal portion ofthe frame of the prosthetic valve to tissue surrounding the nativevalve, at 318. For example, the proximal portion of the frame can beanchored using any of the tissue anchors and/or anchoring methodsdescribed herein. In some implementations, the proximal portion of theframe can be anchored using a tissue anchor that engages a portion ofthe frame and inserted into the tissue surrounding the native valve.

The method 300 optionally may include delivering to an aperture of theprosthetic valve frame a flow control apparatus, at 320. For example, asdescribed above with reference to the valve 102 shown in FIGS. 1A-1F,the valve can be deployed in the annulus of a native valve as a singleintegrated component—the valve including a valve frame and a flowcontrol component disposed in the aperture of the valve frame. In otherembodiments, however, the valve can be deployed in the annulus of anative valve in two or more independent or separate processes. In someinstances, delivering the valve in two or more parts can allow theseparately delivered components to be compressed into a smaller ortighter compressed configuration. In some such instances, the valveframe can be compressed and delivered to the annulus of the native valveas described in the method 300 above. After fully seating or deployingthe valve frame in the annulus of the native valve, the flow controlcomponent can be compressed and delivered to the valve frame. The flowcontrol component can be a self-expanding valve component or can beballoon-expanded once placed in a desired position within the valveframe.

Provided below is a discussion of certain aspects or embodiments oftranscatheter prosthetic valves, delivery systems, and/or deliverymethods. The transcatheter prosthetic valves (or aspects or portionsthereof), the delivery systems, and/or the delivery methods describedbelow with respect to specific embodiments can be substantially similarin at least form and/or function to the valve 202 and/or correspondingaspects of the valve 202, the delivery system 270, and/or the deliverymethod 300 described above with reference to FIGS. 72A-72D. Thus,certain aspects of the specific embodiments are not described in furtherdetail herein.

FIG. 73A is an illustration of a side view of human heart anatomy, andFIG. 73B is an enlarged illustration of a portion of the human heartanatomy of FIG. 73A showing the geometric relationship between theinferior vena cava (IVC), the three leaflet cusps of the tricuspidvalve—anterior, posterior, septal—the RVOT, and the pulmonary artery(PA).

FIG. 74 is an illustration of a side perspective view of a sidedelivered valve 5802 seated with the native tricuspid annulus withcollar portion 5820 of the valve 5802 (or valve frame) laying atriallyabove the tricuspid annulus and leaflets, lower body portion extendinginto and through the annulus to provide corrective hemodynamic flow fromthe flow control component. FIG. 74 also shows a RVOT footer tab or adistal lower tension arm 5832 disposed in the RVOT.

FIG. 75A is an illustration of a plan view of a native right atrium of ahuman heart, and shows the superior vena cava (SVC), the inferior venacava (IVC), the right atrium (RA), the tricuspid valve and annulus(TCV), the anterior leaflet (A), the posterior leaflet (P), the septalleaflet (S), the right ventricle (RV), and the right ventricular outflowtract (RVOT).

FIG. 75B is an illustration of a prosthetic valve 5902 according to anembodiment being delivered to the tricuspid valve annulus. FIG. 75Bshows the valve 5902 having a braided/laser cut-frame 5910 with a distallower tension arm 5932 that is being ejected from a delivery catheter5972 and directed through the annulus and towards the right ventricularoutflow tract.

FIG. 75C is an illustration of the valve 5902 showing the braided/lasercut-frame 5910 with the distal lower tension arm 5932 and the distalupper tension arm 5931 ejected from the delivery catheter 5972 via asecondary catheter and/or pusher 5980, the distal lower tension arm 5932being directed through the annulus and into the RVOT, and the distalupper tension arm 5931 staying in a supra-annular position, and causinga passive, structural anchoring of the distal side of the valve 5902about the annulus.

FIG. 75D is an illustration of the valve 5902 showing the entirebraided/laser cut-frame 5910 ejected from the delivery catheter 5972,the distal lower tension arm 5932 being directed through the annulus andinto the RVOT, the distal upper tension arm 5931 staying in asupra-annular position, and causing a passive, structural anchoring ofthe distal side of the valve about the annulus, and at least one tissueanchor (not shown) anchoring the proximal side of the prosthesis intothe annulus tissue.

FIG. 76A is an illustration of a prosthetic valve 6002 according to anembodiment being delivered to tricuspid valve annulus. FIG. 76A shows adistal lower tension arm 6032 of the valve 6002 ejected from a deliverycatheter and being directed through the annulus and towards the RVOT. Inthis example, delivery of the valve 6002 can include a valve assessmentprocess.

FIG. 76B shows distal lower tension arm 6032 and a distal upper tensionarm 6031 ejected from the delivery catheter, the distal lower tensionarm 6032 is directed through the annulus and into the RVOT, and thedistal upper tension arm 6031 stays in a supra-annular position, andcausing a passive, structural anchoring of the distal side of the valve6002 about the annulus. FIG. 76B shows that the valve 6002 can be held(e.g., by a secondary catheter (not shown)) at an oblique angle in apre-attachment position, so that the valve can be assessed, and oncevalve function and patient conditions are correct, the secondarycatheter can push the proximal side of the valve 6002 from its obliqueangle, down into the annulus. By allowing two pathways for blood flow,the first through the native valve near the posterior leaflet, and thesecond through the central aperture of the prosthetic valve 6002, apractitioner can determine if the heart is decompensating or if valvefunction is less than optimal. The secondary catheter can then installone or more anchoring elements or otherwise secure the valve 6002 in thenative valve.

FIG. 76C is an illustration of the valve 6002 showing the entirebraided/laser cut-frame valve 6002 ejected from the delivery catheter,the distal lower tension arm 6032 is directed through the annulus andinto the RVOT, the distal upper tension arm 6031 stays in asupra-annular position, and causes a passive, structural anchoring ofthe distal side of the valve 6002 about the annulus, and optionally atleast one tissue anchor (not shown) anchoring the proximal side of thevalve 6002 into the annulus tissue.

FIG. 77A is an illustration of a side perspective view of a valve 6102that is vertically compressed without folding into a compressedconfiguration and loaded into a delivery catheter 6172. By usinghorizontal rather than traditional vertical diamond shaped cells, aframe 6110 of the valve 6102 can be compressed from top to bottom. Thisallows for orthogonal delivery of a much larger diameter valve than canbe delivered using traditional axial compression. Additionally, theorthogonal delivery provides access from the IVC to the tricuspidannulus using a subannular distal-side anchoring tab or distal lowertensioning arm 6132. Normally, a delivery catheter would need to make a90-120 degree right turn before expelling a traditional transcatheteraxially compressed valve. In contrast, the vertically compressed valve6102 (e.g., compressed in the direction of a central aperture or thedirection of blood flow through the valve 6102) can be directly expelledinto the distal side of the tricuspid annulus.

FIG. 77B is an illustration of a side perspective view of the valve 6102being partially expelled or released from the delivery catheter 6172that allows a transition from native blood flow through the nativetricuspid valve and a partial flow around the prosthetic valve 6102 andinto the native annulus to a partial flow through an inflow end(indicated in FIG. 77B by the arrow labeled “Inflow”) and out of anoutflow end (indicated in FIG. 77B by the arrow labeled “Outflow”) ofthe prosthetic valve 6102 into the native annulus. A guide wire 6185 isshown pig-tailed into the pulmonary artery of the heart. A rigid pullrod/wire, pusher, and/or secondary catheter 6180 in some embodiments isengineered to ride over the guide wire 6185, thus allowing the valve6102 to be delivered exactly where intended. The distal subannular tabor distal lower tension arm 6132 is directed into the RVOT and isconfigured to provide anchoring for the valve 6102 while it ispositioned and assessed.

FIG. 77C is an illustration of a side perspective view of the valve 6102being fully expelled or released from the delivery catheter 6172 into anexpanded configuration. The valve 6102 is lodged using the distal tab ordistal lower tension arm 6132 against the distal surface of the annulusand held using the rigid pull rod/wire or pusher 6180 at an elevatedangle above the native annulus prior to complete deployment of the valve6102. This allows a further transition from native blood flow throughthe native tricuspid valve with a partial flow around the prostheticvalve 6102 and into the native annulus, and an increasing partial flowthrough the inflow end and out of the outflow end of the prostheticvalve 6102 into the native annulus. FIG. 77C also shows the guide wire6185 pig-tailed into the pulmonary artery of the heart (through theLVOT). FIG. 77C further shows a proximal subannular anchoring tab orproximal lower tension arm (proximal tab) 6134, which can facilitate themounting or anchoring for the valve 6102 once entirely deployed in thenative annulus.

FIG. 77D is an illustration of a side perspective view of the valve 6102being fully expelled or released from the delivery catheter 6172 andcompletely seated into the native annulus. The delivery of the valve6102 just described allows a smooth transition from native blood flow toa full, complete flow through the prosthetic valve 6102 and thus, thenative annulus. The valve 6102 is anchored using subannular distal tab(distal lower tension arm) 6132, the subannular proximal tab (proximallower tension arm) 6134, and a supra-annular (atrial) upper tension arm(distal upper tension arm) 6131. Corrected replacement flow using thevalve 6102 is shown by Inflow through the inflow end and Outflow throughthe outflow end of the prosthetic valve 6102 and thus, the nativeannulus.

FIG. 78A is an illustration of a side perspective view of a valve 6202that is vertically compressed without folding, into a compressedconfiguration and loaded into a delivery catheter 6272 and shows a flowcontrol component 6250 in a rolled configuration. A guide wire 6285 andan RVOT tab or distal lower tension arm 6232 are shown extended into thepulmonary artery and allowing the valve 6202 to be precisely delivered.

FIG. 78B is an illustration of a side perspective view of the valve 6202being partially expelled or released from the delivery catheter 6272,with inner leaflets 6253 of the flow control component 6250 partiallyunfurled and extended. FIG. 78B shows a transition from native bloodflow through the native tricuspid valve to a partial flow around theprosthetic valve 6202 and into the native annulus to a partial flowthrough an inflow end (indicated in FIG. 78B by the arrow labeled“Inflow”) and out of an outflow end (indicated in FIG. 78B by the arrowlabeled “Outflow”) of the prosthetic valve 6202 into the native annulus.A rigid pull rod/wire, pusher, and/or secondary catheter 6280 in someembodiments is engineered to ride over the guide wire 6285. The RVOT tabor distal lower tension arm 6232 is directed into the RVOT and isconfigured to provide anchoring for the valve 6202 while it ispositioned and assessed. The valve 6202 has a distal mid-wall arch abovethe RVOT tab or distal lower tension arm 6232 for engaging the nativeannulus.

FIG. 78C is an illustration of a side perspective view of the valve 6202being fully expelled or released from the delivery catheter 6272 into anexpanded configuration, with the inner leaflets 6253 of the flow controlcomponent 6250 a fully unfurled and extended. The valve 6202 is lodgedusing the distal tab or distal lower tension arm 6232 against the distalsurface of the annulus and held elevated using the rigid puller/pusheror secondary catheter 6280 at an angle above the native annulus prior tocomplete deployment. This allows a further transition from native bloodflow through the native tricuspid valve with a partial flow around theprosthetic valve 6202 and into the native annulus, and an increasingpartial flow through the inflow end and out of the outflow end of theprosthetic valve 6202 into or through the native annulus. FIG. 78C showsthe distal mid-wall arch engaging the distal native annulus and shows aproximal mid-wall arch raised above the native annulus in preparationfor a smooth transition to prosthetic flow when the valve 6202 is fullyseated in the native annulus.

FIG. 78D is an illustration of a side perspective view of the valve 6202being fully expelled or released from the delivery catheter 6272 andcompletely seated into the native annulus. The delivery of the valve6202 just described allows a smooth transition from native blood flow toa full, complete flow through the prosthetic valve 6202 and thus, thenative annulus. The valve 6202 is anchored using subannular distal tabor distal lower tension arm 6232, a subannular proximal tab or proximallower tension arm 6234, and a supra-annular (atrial) tab or distal uppertension arm 6231. Corrected replacement flow through unfurled andextended leaflets 6253 is shown by Inflow through the inflow end andOutflow through the outflow end of the prosthetic valve 6202 and thus,the native annulus.

FIG. 79A is an illustration of a side view of a valve 6302 in acompressed configuration within a delivery catheter 6372 according to anembodiment. FIG. 79A shows how a central tube/wire or secondary catheter6380 can be distally attached to a distal edge, RVOT tab, or distallower tension arm 6332 and by pushing on the rigid tube/wire orsecondary catheter 6332, the compressed valve 6202 can be pulled fromthe proximal end of the catheter 6372 to the distal deployment end ofthe delivery catheter 6372. This pulling action avoids pushing the valve6302 out of the delivery catheter 6302, which may cause additionalradial expansion and radial forces that can damage the valve 6302 whenit is compressed within the delivery catheter 6372.

FIG. 79B is an illustration of a side view of the valve 6302 beingpartially compressed and partially released from the delivery catheter6372 and shows how blood flow can begin to transition. The gradual,smooth transition from native flow to flow through the prosthetic valve6302 by pulling on the valve 6302 using the rigid pusher or secondarycatheter 6380 attached to the distal subannular anchoring tab or distallower tension arm 6332 avoids the sphincter effect where the heart iscut off from the flow, resulting in a dry pump action, which can causeheart failure. When the valve 6302 is partially open (partiallyreleased) exposing only a part of a collar portion 6320 of a frame ofthe valve 6302 on a small fraction of right atrial blood flow goingthrough the prosthetic valve 6302, the washing effect provides for asmooth transition to a larger volume going through the valve 6302.

FIG. 79C is an illustration of a side view of the valve 6302 beingpartially compressed and partially released from the delivery catheter6372 and shows how blood flow can begin its transition. The gradual,smooth transition from native flow to flow into the valve 6302 throughan inflow end (indicated in FIG. 79C by the arrow labeled “Inflow”) andout of an outflow end (indicated in FIG. 79C by the arrow labeled“Outflow”) of the prosthetic valve 6302 by pulling from the distalsubannular anchoring tab or distal lower tension arm 6332 avoids thesphincter effect where the heart is cut off from the flow, resulting ina dry pump action, and causing heart failure. When the valve ispartially open exposing only a part of the collar portion 6320 on asmall fraction of right atrial blood flow initially going through theprosthetic valve 6302, with an increasing amount transitioning from flowaround the valve 6302 to flow going through the valve 6302, the washingeffect provides for a smooth transition to a larger volume going throughthe valve 6302.

FIG. 79D is an illustration of a side view of valve 6302 being fullyexpanded or uncompressed into the expanded configuration andorthogonally released from the delivery catheter 6372, and stillreleasably attached to the distal pull wire/deployment control wire orhypotube (secondary catheter) 6380 via the distal tab/RVOT tab or distallower tension arm 6332. The collar portion 6320 and lower body portion6312 of the frame are fully expanded, permitting functioning of the flowcontrol component 6350. FIG. 79D shows that the valve can be positionedor re-positioned by using the rigid pull wire 310. Since the blood flowis not blocked, an interventionist is allowed the opportunity and timeto ensure correct orientation of the valve 6302, especially where thedistal tab (mitral)/RVOT tab (tricuspid) or distal lower tension arm6332 is used to assist in anchoring. Once proper orientation isachieved, the valve 6302 can be slowly seated into the native tricuspidannulus, providing a smooth blood flow transition from the native flowto the prosthetic flow. FIG. 79D also shows a release mechanism 6382 forreleasing the rigid pull device or secondary catheter 6380 from thevalve body or distal lower tension arm 6332 by pulling on a trigger wirethat is attached to a release hook, lock, bead, or other releasemechanism.

FIG. 79E is an illustration of a side view of the valve 6302 being fullyexpanded or uncompressed showing transition to all blood flow throughthe flow control component 6350 of the valve 6302 and no flow around thevalve 6302 during or resulting from atrial sealing of an anterior collarportion 6321 and a posterior-septal collar portion 6322 against theatrial floor.

FIG. 80A is an illustration of a side view of a valve 6402 being rolledinto a compressed configuration within a delivery catheter 6472 andbeing advanced by a distal rigid pull wire/draw-wire or secondarycatheter 6480 (or far-side push-pull wire) attached to a leading edge ofa collar 6420 of a valve frame 6410.

FIG. 80B is an illustration of a side view of valve 6402 being partiallyunrolled and deployed from the delivery catheter 6472 by action of thepushing rod or secondary catheter 6480 on the distal upper edge of thecollar 6420.

FIG. 80C is an illustration of a side view of the valve 6402 beingpartially unrolled and deployed from the delivery catheter 6472, andshows the pushing rod or secondary catheter 6480 maintaining connectionto the valve 6401 while an anterior collar portion 6421 is unrolled andleaflets 6453 of a flow control component are uncovered.

FIG. 80D is an illustration of a side view of valve 6402 beingcompletely released and unrolled into the expanded configuration wherethe rigid pull device or secondary catheter 6480 is used to position thevalve 6402 within the native annulus and obtain a good perivalvular sealvia the anterior collar portion 6421 and a posterior-septal collarportion 6422 to transition to blood flow through the leaflets 6453. FIG.80D also shows the release mechanism 6482 for releasing the rigid pulldevice or secondary catheter 6480 from the valve body or collar 6420 bypulling on a trigger wire that is attached to a release hook, lock,bead, or other release mechanism.

FIG. 80E is an illustration of a side view of a valve 6502 according toan embodiment. FIG. 80E shows that the valve 6502 can have a combinationwire cell frame construction as described above with reference to FIG.34A and can be compressed into a compressed configuration within adelivery catheter 6572, and shows that a draw/pulling wire or secondarycatheter 6580 can be attached to a forward end of the compressed valve6502 and can be pushed to pull the valve 6502 through and/or out of thedelivery catheter 6572. FIG. 80E also shows the valve 6502 and thedraw/pulling wire or secondary catheter 6580 being positioned over aguidewire 6585.

FIG. 81A is an illustration of a side or plan transparent view of adelivery catheter 6672 loaded with a side-delivered (orthogonal) valve6602 in a compressed configuration. The valve 6602 has a frame with atension arm (e.g., a distal lower tension arm) 6632, a guidewire collarelement 6640 attached to the tension arm 6632, and a guidewire 6685extending through the guidewire collar element 6640 with a guidewiresheath or secondary catheter 6680 pushing against the guidewire collarelement 6640. The enlarged inset shows a non-limiting example of theguidewire collar element 6640 attached to the tension arm 6632 with theguidewire 6685 extending through an aperture defined by the guidewirecollar element 6640 and the hypotube sheath or secondary catheter 6680stopped against the guidewire collar element 6640 by the largercircumference of the guidewire collar element 6640, permitting pushingon the tension arm (e.g., the distal lower tension arm) 6632 to pull thevalve 6602 through and/or out of the delivery catheter 6672.

FIG. 81B is another non-limiting example of a guidewire collar element6640A attached to the tension arm 6632 with the guidewire 6685 extendingthrough the aperture of the guidewire collar element 6640A and thehypotube sheath or secondary catheter 6680 stopped by the largercircumference of the hypotube sheath or secondary catheter 6680 relativeto the aperture defined by the guidewire collar element 6640A,permitting pushing on the tension arm (e.g., the distal lower tensionarm) 6632 to pull the valve 6602 out of the delivery catheter 6672. FIG.81B shows the tension arm 6632 being substantially hollow or annular,defining a lumen that extends therethrough. The guidewire collar element6640A is shown as a structure (e.g., a rounded structure) thatconstricts the lumen that extends through the tension arm 6632, thehypotube sheath or secondary catheter 6680 having a circumference thatis larger than the constriction permitting pushing on the tension arm(e.g., the distal lower tension arm) 6632 to pull the valve 6602 throughand/or out of the delivery catheter 6672.

FIG. 81C is another non-limiting example of a guidewire collar element6640B attached to the tension arm 6632 with the guidewire 6685 extendingthrough the aperture of the guidewire collar element 6640B and thehypotube sheath or secondary catheter 6680 stopped by the guidewirecollar element 6640B as it slides over the guidewire 6685—the guidewireis in the lumen of the hypotube sheath or secondary catheter 6680—by thelarger circumference of the hypotube sheath or secondary catheter 6680relative to the aperture defined by the guidewire collar element 6640B,permitting pushing on the tension arm (e.g., the distal lower tensionarm) 6632 to pull the valve 6602 through and/or out of the deliverycatheter 6672.

FIG. 81D is another non-limiting example of a guidewire collar element6640C attached to the tension arm 6632 with the guidewire 6685 extendingthrough the aperture of the guidewire collar element 6640C and thehypotube sheath or secondary catheter 6680 stopped by the largercircumference of the hypotube sheath or secondary catheter 6680 relativeto the guidewire collar element 6640C, permitting pushing on the tensionarm (e.g., the distal lower tension arm) 6632 to pull the valve 6602through and/or out of the delivery catheter 6672.

FIGS. 82A-82C are various schematic illustrations of a delivery system470 for delivering a transcatheter prosthetic valve 402 according to anembodiment. The transcatheter prosthetic valve 402 is configured todeployed in a desired location within a body (e.g., of a human patient)and to permit blood flow in a first direction through an inflow end ofthe transcatheter prosthetic valve 402 and to block blood flow in asecond direction, opposite the first direction, through an outflow endof the transcatheter prosthetic valve 402. For example, thetranscatheter prosthetic valve 402 can be a transcatheter prostheticheart valve configured to be deployed within the annulus of a nativetricuspid valve or native mitral valve of a human heart to supplementand/or replace the functioning of the native valve.

The transcatheter prosthetic valve 402 is compressible and expandable inat least one direction perpendicular to a long-axis of the valve 402.The valve 402 is configured to compressible and expandable between anexpanded configuration for implanting at a desired location in a body(e.g., a human heart) and a compressed configuration for introductioninto the body via the delivery system 470.

In some embodiments, the prosthetic valve 402 can be similar to orsubstantially the same as the valve 102 described above with referenceto FIGS. 1A-1F. For example, FIG. 82B shows that the valve 402 caninclude an annular support frame 410 and a flow control component 450.The annular support frame 410 can be similar to the frame 110 and caninclude a cuff or collar portion 420 and a tubular section (e.g., alower tubular body portion) 412, and a guidewire collar 440. Inaddition, the annular support frame 410 (referred to herein as “frame”)defines an aperture 414 that extends along or in the direction of acentral axis 413 of the frame 410. While not shown, the frame 410 and/orthe valve 402 can also include one or more tension arms, anchoring tabs,and/or the like. The flow control component 450 can be similar to theflow control component 150 described above with reference to FIGS.1A-1F. The valve 402 being substantially similar to the valve 102, isnot described in further detail herein.

As shown in FIGS. 82A-82C, the delivery system 470 includes a deliverycatheter 472, a capsule 476, a secondary catheter 480, and a guidewire485. The delivery system 470 can be configured to orthogonally deliverthe compressed valve 402 and/or portions of the valve 402 (e.g., thecompressed frame 410 or the compressed flow control component 450) to adesired location in the body such as, for example, the annulus of anative tricuspid valve and/or the annulus of a native mitral valve ofthe human heart. As described in detail above with reference to thevalve 102, the delivery system 470 can orthogonally deliver the valve402, which has been compressed to the compressed configuration by beingcompressed along the central axis 413 (FIG. 82B) or compressed in alateral direction (e.g., orthogonal to the central axis 413 and acentral lengthwise axis 475 of the delivery catheter 472). Suchcompression can result in elongation of the valve 402 along alongitudinal axis (not shown in FIGS. 82A-82C), which is substantiallyparallel to the central lengthwise axis 475 of the delivery catheter472.

The delivery catheter 472 defines a lumen 474 that extends along or inthe direction of the central lengthwise axis 475. The lumen 474 of thedelivery catheter 472 can have a diameter sufficient to receive thecompressed valve 402 therethrough. For example, the delivery catheter472 can be 22-34 Fr.

The capsule 476 is configured to facilitate placement into the deliverycatheter 472 of the valve 402 in the compressed configuration. FIG. 82Ashows the valve 402 and at least a portion of the secondary catheter480, the pusher 481, the release mechanism 482, and the guidewire 485disposed within the capsule 476, which in turn, is positioned within orat the proximal end portion of the delivery catheter 472. As describedin detail above, the valve 402 can be compressed from a configuration inwhich a circumference of the valve 402 in a plane orthogonal to thelengthwise axis 475 of the delivery catheter 472 is greater than thecircumference or diameter of the lumen 474 of the delivery catheter 472.The capsule 476 can be configured to compress the valve 402 to thecompressed configuration, or to receive the valve 402, which has alreadybeen compressed to the compressed configuration, such that thecircumference of the compressed valve 402 within the capsule 476 is lessthan the circumference or diameter of the lumen 474 of the deliverycatheter 472.

The capsule 476 can be any suitable capsule, catheter, compressionmember, and/or device configured to compress the valve 402 into thecompressed configuration or to receive the valve 402, which has alreadybeen compressed to the compressed configuration. In some embodiments,the capsule 476 can be a compression catheter or sleeve configured toexert a compression force (e.g., squeeze) the valve 402. In someembodiments, the capsule 476 can be configured to maintain the valve 402in a rolled or folded configuration (e.g., compressed configuration)prior to the valve 402 being delivered into the delivery catheter 472.In some embodiments, the delivery system 470 can include a tapering orfunnel fixture that can compress the valve 402 to the compressedconfiguration, which can then be inserted into the capsule 476. In someembodiments, the capsule 476 can be configured to deliver the valve 402to the proximal end of the delivery catheter 472 and once delivered, canbe removed and/or the valve 402 can be ejected from the capsule 476 intothe delivery catheter 472. In other embodiments, the valve 402 canremain within the capsule 476, which are advanced, collectively, throughthe delivery catheter 472.

The guidewire 485 extends or threads through the secondary catheter 480,the valve 402, and the delivery catheter 472. The guidewire 485 can be,for example, a sheathed guidewire at least partially sheathed by thesecondary catheter 480. The guidewire 485 is configured to be advancedthrough the anatomy of the body and placed in a desired positionrelative to native tissue (e.g., a native valve). In some instances, theguidewire 485 can be advanced to provide a wire path (e.g., for thedelivery catheter 472, the valve 402, etc.) to the RVOT. The guidewire485 extends through the guidewire collar 440 of the valve 402 to providea wire path along which the valve 402 is advanced.

The secondary catheter 480 can be a sheath, tube, annular rod or wire,and/or the like. In some embodiments, the secondary catheter 480 is ahypotube sheath disposed about a portion of the guidewire 485 (e.g., thesecondary catheter 480 and the guidewire 485 collectively form asheathed guidewire or sheathed guidewire assembly). The secondarycatheter 480 can have a relatively small size allowing the secondarycatheter 480 to be advanced through the delivery catheter 472 and/or atleast partially disposed in or otherwise engaged with the guidewirecollar 440. As shown in FIGS. 82A-82C, the secondary catheter 480 has adiameter that is greater than the guidewire 485, allowing the guidewire485 to pass therethrough.

The pusher 481 is disposed within the secondary catheter 480 and isconfigured to push on a portion of the valve 402 to advance the valve402 through and/or out of the delivery catheter 472. In someimplementations, the pusher 481 is configured to push against a portionof the guidewire collar 440 of the valve 402. For example, the guidewirecollar 440 can allow the guidewire 485 to be advanced through theguidewire collar 440 and can block and/or substantially prevent thepusher 481 from being advanced beyond the guidewire collar 440 (or atleast a portion thereof). While the pusher 481 is shown disposed in thesecondary catheter 480, in some embodiments, the secondary catheter 480can be used as the pusher 481. In such embodiments, the delivery system470 need not include a separate pusher 481.

The guidewire collar 440 of the valve (FIG. 82B) can be any suitableelement that selectively allows the guidewire 485 to be advancedtherethrough while blocking or preventing the advancement of thesecondary catheter 480 and/or the pusher 481 beyond the guidewire collar440. In some embodiments, the guidewire collar 440 can be included in,formed by, and/or attached to the cuff 420 of the frame 410. In someembodiments, guidewire collar 440 can be included in, formed by, and/orattached to a tension arm such as, for example, a distal upper tensionarm, a distal lower tension arm, and/or the like. In certainembodiments, the distal lower tension arm can form and/or can include afeature that forms the guidewire collar 440. It may be desirable toattach the guidewire collar 440 to the distal lower tension arm sinceboth the guidewire 485 and the distal lower tension arm are insertedinto or directed toward the RVOT.

In some embodiments, the guidewire collar 440 can be a ball or featureof a tension arm that defines an aperture or lumen that is sufficientlylarge to allow the guidewire 485 to pass through but is not sufficientlylarge to allow the secondary catheter 480 and/or the pusher 481 to beadvanced therethrough. As such, the secondary catheter 480 and/or thepusher 481 can be stopped against the guidewire collar 440 by the largercircumference of the secondary catheter 480 and/or pusher 481 relativeto the aperture or lumen of the guidewire collar 440. Such anarrangement allows the secondary catheter 480 and/or pusher 481 to pushon the guidewire collar 440 and thus, the tension arm (e.g., the distallower tension arm) to which it is attached. When the guidewire collar440 is attached to a distal tension arm, the pushing on the guidewirecollar 440 is operative to pull the valve 402 through and/or out of thedelivery catheter 472. It is contemplated that the guidewire collar 440can have any suitable configuration that allows the guidewire collar 440to permit the advancement of the guidewire 485 while limiting, blocking,or preventing advancement of the secondary catheter 480 and/or thepusher 481. Moreover, the release mechanism 482 can be configured torelease the guidewire 485, the secondary catheter 480 and/or the pusher481 from the guidewire collar 440, for example, after deployment of thevalve 402.

FIG. 82C shows the delivery system 470 delivering the valve 402 to anative valve such as a mitral valve or pulmonary valve (or tricuspidvalve or aortic valve). The guidewire 485 is advanced to through theannulus of the native valve and disposed within the ventricle (e.g.,within the right ventricle outflow tract. The delivery catheter 472 canbe advanced over the guidewire 485 and delivered to the desired locationat or near the annulus. The valve 402 can be placed in the compressedconfiguration (e.g., by rolling, folding, and/or a combination thereof)and can be disposed within the capsule 476. Once the delivery catheter472 is in the desired location and the compressed valve 402 is in thecapsule 476, the capsule 476 can be used to deliver the compressed valve402 into the lumen 474 of the delivery catheter 472.

FIG. 82A shows the capsule 476 delivering the compressed valve 402 intothe proximal end of the delivery catheter 472. In some instances, oncethe valve 402 is in the lumen 474 of the delivery catheter 472, thecapsule 476 can be removed and/or the valve 402 can be ejected from thecapsule 476. In other embodiments, the valve 402 can remain in thecapsule 476 as the valve 402 is advanced through the delivery catheter472. The valve 402 can be advanced over the guidewire 485 and within thedelivery catheter 472 by pushing on the secondary catheter 480 and/orpusher 481. When the guidewire collar 440 is attached to a distal oranterior side of the valve 402 or frame 410, the pushing of thesecondary catheter 480 and/or pusher 481 acts like a pulling forcerelative to, for example, the tubular section 412 of the valve frame 410and/or the flow control component 450 of the valve 402.

FIG. 82C shows the valve 402 partially ejected from the deliverycatheter 472 and completely ejected from the capsule 476. The ejectingof the valve 402 from the capsule 476 and the delivery catheter 472 canbe a single integrated process or step or can be performed in any numberof independent processes and/or steps. Alternatively, the capsule 476can be removed once the valve 402 is delivered into the lumen 474 of thedelivery catheter 472.

The secondary catheter 480 and/or the pusher 481 can be used to ejectthe valve 402 from the delivery catheter 472. Once ejected from thedelivery catheter 472, the valve 402 is allowed to expand to theexpanded configuration and can be seated within the annulus of thenative valve. In some embodiments, secondary catheter 480, the pusher481, and/or the guidewire 485 can be released from the guidewire collar440 to allow the secondary catheter 480, the pusher 481, and/or theguidewire 485 to be retracted and/or withdrawn. In some embodiments, thesecondary catheter 480 and/or the pusher 481 can be used to push atleast a proximal side of the valve 402 or valve frame 410 into theannulus, thereby completely seating and/or deploying the valve 402.Although not shown in FIGS. 82A-82C, in some embodiments the secondarycatheter 480 and/or pusher 481 can be further used to deliver and/oranchor a tissue anchor to the proximal side of the valve 402 or valveframe 410. Thus, the delivery system 470 can deliver a traditionallycompressed valve or orthogonally deliver a vertically and/or laterallycompressed valve 402. Moreover, the delivery system 470 includes thecapsule 476, which can maintain the valve 402 in the compressedconfiguration at least until the valve 402 is delivered into thedelivery catheter 472.

FIG. 82D is a flowchart describing a method 500 for delivering acompressible prosthetic valve such as any of the prosthetic valvesdescribed herein, according to an embodiment. The method 500 includesadvancing over a guidewire a delivery catheter to dispose a distal endof the delivery catheter at a desired location within a body, at 502.The desired location within the body can be, for example, an annulus ofa native valve within the human heart. Prior to advancing the deliverycatheter, the guidewire can be advanced into the desired location andplaced, for example, within a right ventricle outflow tract or inanother desired position relative to the annulus.

A valve capsule is mounted onto a proximal end of the guidewire, wherethe valve capsule contains a prosthetic valve in a compressedconfiguration and having a guidewire collar with an aperturetherethrough having an internal diameter larger than the diameter of theguidewire, with the guidewire disposed through the aperture, at 504. Thearrangement of the prosthetic valve, guidewire collar, guidewire, andcapsule can be substantially similar to the arrangement described abovewith reference to the delivery system 470. In some embodiments, thevalve capsule can be configured to place and/or to maintain theprosthetic valve in the compressed configuration prior to the prostheticvalve being delivered and/or loaded into the delivery catheter.

The valve capsule is loaded into a proximal end of the deliverycatheter, at 506. The valve capsule can have an outer diameter orcircumference that is smaller than the diameter or circumference of thelumen of the delivery catheter, thereby allowing the valve capsule to bedisposed within the lumen. Moreover, the valve capsule can maintain theprosthetic valve in the compressed configuration and the loading of thevalve capsule similarly loads the prosthetic valve into the proximal endof the delivery catheter.

Proximal to the prosthetic valve, a pusher is disposed over theguidewire, wherein the pusher has an outside diameter larger than theinside diameter of the aperture in the guidewire collar, at 508. Thepusher can be similar to the pusher 481 described above with referenceto FIGS. 82A-82C. In some embodiments, the pusher can be a secondarycatheter or the like that can form a sheath of the guidewire. In otherembodiments, the pusher can be inserted into or at least partiallydisposed within the secondary catheter.

The prosthetic valve is advanced distally from the valve capsule intoand through the lumen of the delivery catheter to the distal end of thedelivery catheter, at 510. In some embodiments, the loading and/ordelivery of the valve capsule into the proximal end of the deliverycatheter can begin to eject the prosthetic valve from the valve capsuleas the valve capsule is moved relative to or within the deliverycatheter. In other embodiments, the prosthetic valve can remain withinthe valve capsule until the prosthetic valve is at or near the distalend of the delivery catheter. In some embodiments, the valve capsule canbe a compression catheter or sleeve that can be slid off or relative tothe prosthetic valve to allow the prosthetic valve to move distally fromthe valve capsule. As described above with reference to the deliverysystem 470, the prosthetic valve can be advanced distally by pushing onthe pusher and/or the second catheter, which in turn, can push or pullthe prosthetic valve in the distal direction through the deliverycatheter.

The prosthetic valve is deployed from the distal end of the deliverycatheter to the desired location, at 512. As described above, the pusheror secondary catheter can be used to eject the prosthetic valve from thedistal end of the delivery catheter. Moreover, the prosthetic valve cansimilarly be advanced relative to or ejected from the valve capsule.Thus, when the prosthetic valve is disposed outside of and distal to thedelivery catheter (e.g., within the atrium of the heart), the prostheticvalve can be allowed to expand to an expanded configuration suitable fordeployment into the annulus of the native valve. In some instances, thepusher and/or the secondary catheter can be used to push the prostheticvalve into the annulus of the native valve, and the prosthetic valve canform a seal with the native annular tissue when deployed therein.

Provided below is a discussion of certain aspects or embodiments oftranscatheter prosthetic valves, delivery systems, and/or deliverymethods. The transcatheter prosthetic valves (or aspects or portionsthereof), the delivery systems, and/or the delivery methods describedbelow with respect to specific embodiments can be substantially similarin at least form and/or function to the valve 402 and/or correspondingaspects of the valve 402, the delivery system 470, and/or the deliverymethod 500 described above with reference to FIGS. 82A-82D. Thus,certain aspects of the specific embodiments are not described in furtherdetail herein.

FIGS. 83A-83F illustrate a process for delivery of an orthogonaltranscatheter prosthetic valve 6702 to the tricuspid annulus of thehuman heart. FIG. 83A is an illustration of a first step of the deliveryprocess in which a guidewire 6785 with a hypotube sheath or secondarycatheter 6780 is delivered to the RVOT. The guidewire 6785 has adiameter of about 0.035 in (or about 0.889 mm).

FIG. 83B shows a delivery catheter 6772 being advanced over theguidewire 6772 to and through the native tricuspid annulus to the rightventricle.

FIG. 83C shows the valve 6702 in a compressed configuration disposedwithin a capsule/compression catheter 6776. The capsule 6776 is loadedinto a proximal end of the delivery catheter 6772 and the valve 6702 iswithdrawn from the capsule 6776 into the delivery catheter 6772, withthe sheathed guidewire 6785 threaded through the valve 6702 andproviding a wire path to the RVOT, planned deployment location. Inanother embodiment, the capsule 6776 with the valve 6702 disposedtherein can be advanced through at least part of the delivery catheter6772. The guidewire 6785 can extend through a guidewire collar element6740 of the valve 6702 while the larger circumference of the hypotubesheath or secondary catheter 6780 relative to an aperture of theguidewire collar element 6740 blocks passage of the hypotube sheath orsecondary catheter 6780 through the guidewire collar element 6740.

FIG. 83D shows the valve 6702 being expelled and/or released out of thedelivery catheter 6772 into the expanded configuration and deployed intothe native annulus by pushing on the hypotube sheath or secondarycatheter 6780 against the guidewire collar element 6740 to pull thevalve 6702 through the delivery catheter 6772 and into position in thenative tricuspid annulus. The tension arm (e.g., the distal lowertension arm) 6732 is used to position the expanded valve 6702 in thenative annulus.

FIG. 83E shows the secondary catheter 6780, or steerable catheter, beingused to push the proximal side of the valve 6702 into position withinthe native annulus.

FIG. 83F shows withdrawal of the delivery system (e.g., the guidewire6785 and the delivery catheter 6772) and anchoring of a proximal side(e.g., a posterior-septal side) of the valve 6702 to the annular tissue.FIG. 83F shows the expanded valve 6702 with an atrial sealing collarfacing the atrium, a valve body (e.g., a lower tubular body portion)deployed within the native annulus and extending from atrium toventricle, the anchoring tension arm or distal lower tension arm 6732extending subannularly into the RVOT area, and the guidewire collar/ball6740 at a distal end of the tension arm 6732. The guidewire 6785 and thedelivery catheter 6772 are being withdrawn.

FIGS. 84A-84F illustrate a process for delivery of an orthogonaltranscatheter prosthetic valve 6802 to the tricuspid annulus of thehuman heart. FIG. 84A is an illustration of a first step of the deliveryprocess in which a guidewire 6885 is advanced from the femoral artery,through the inferior vena cava (IVC), to the right atrium. The guidewire6885 is an 8 Fr guidewire (or about 2.667 mm in diameter).

FIG. 84B shows a balloon catheter 6889 advanced over the guidewire 6885through the native annulus and into the RVOT to expand and push asidenative valve and leaflet tissue, chordae tendineae that might tangle thetranscatheter delivery of the valve 6802.

FIG. 84C shows a guidewire 6885 with a hypotube sheath or secondarycatheter 6880 delivered to the RVOT. The guidewire 6885 has a diameterof about 0.035 in (or about 0.889 mm).

FIG. 84D shows a delivery catheter 6872 being advanced over theguidewire 6872 to and through the native tricuspid annulus to the rightventricle.

FIG. 84E shows the valve 6802 in a compressed configuration disposedwithin a capsule/compression catheter 6876. The capsule 6876 is loadedinto a proximal end of the delivery catheter 6872 and the compressedvalve 6802 is advanced through the delivery catheter 6872, with thesheathed guidewire 6885 threaded through the valve 6802 and providing awire path to the RVOT, planned deployment location.

FIG. 84F shows the valve 6802 advanced though the delivery catheter6872, expelled, expanded to the expanded configuration, and at leastpartially deployed into the native annulus by pushing on the outersheath or secondary catheter 6880 of the guidewire 6885 to pull thevalve 6802, pulling from a guidewire collar 6840 included in or coupledto a distal end of a tension arm (e.g., a distal lower tension arm)6832, through the delivery catheter 6872 and into position in the nativeannulus. The tension arm 6832 is used to position the valve 6802.

FIG. 84G shows the hypotube sheath or secondary catheter 6880, orsteerable catheter, being used to push the proximal side of the valve6802 nearest the IVC or access point into position within the tricuspidannulus.

FIG. 84H shows withdrawal of the delivery system (e.g., the guidewire6885 and the delivery catheter 6872) and anchoring of a proximal side(e.g., a posterior-septal side) of the valve 6802 to the annular tissue,and anchoring of the distal side of the valve 6802 using the distalsubannular anchoring tension arm 6832. The guidewire 6885 and thedelivery catheter 6872 are withdrawn.

FIGS. 85A-85F illustrate a process for delivery of an orthogonaltranscatheter prosthetic valve 6902 to the tricuspid annulus of thehuman heart. FIG. 85A is an illustration of a first step of the deliveryprocess and shows the compressed side-deliverable valve 6902 disposed ina delivery catheter 6972 and advanced therethrough using a pushingsheath or rod or secondary catheter 6980. The delivery catheter 6972 isadvanced over a guidewire 6985 to the native annulus by following thetrack of the guidewire 6985, which is at least partially disposed in alumen of the pushing sheath or secondary catheter 6980.

FIG. 85B shows pushing on the outer sheath or secondary catheter 6980along with the guidewire 6985 threaded through a guidewire collarelement 6940 included in and/or coupled to a tension arm (e.g., a distallower tension arm) 6932 of the valve 6902 to pull the valve 6902 up thedelivery catheter 6972 and into position, partially expelling the valve6902 with the tension arm 6932 being placed into the RVOT and the distalside of the valve 6902 lodged against the native annular wall.

FIG. 85C shows the valve 6902 fully expelled from the delivery catheter6972 into the expanded configuration and the pushing catheter orsecondary catheter 6980 extending from the delivery catheter 6972 beingused to push a proximal side of the valve 6902 into position within thenative tricuspid annulus.

FIG. 85D shows how the tension arm (e.g., the distal lower tension arm)6932 is used to position the valve 6902 while the pushing catheter orsecondary catheter 6980 is used to push the proximal side of the valve6902 into position within the native annulus to allow a proximalsubannular anchoring tab (proximal tab) or proximal lower tension arm6934 to engage and secure the valve 6902 against the native tissue.

FIG. 85E shows how the pushing catheter and/or secondary catheter 6980can be used to deliver a tissue anchor 6990 used to secure the proximalside of the valve 6902 to the native annular tissue.

FIG. 85F shows withdrawal of the delivery system (e.g., the secondarycatheter 6980, the guidewire 6985, and the delivery catheter 6972) andanchoring of the proximal side of the valve 6902 to the native annulartissue via the tissue anchor 6990. The secondary catheter 6980 can beused to push the tissue anchor 6990 into the native annular tissue tosecure the tissue anchor 6990 to the native annular tissue.

FIGS. 86A-86F illustrate a process for delivery of a transcatheterprosthetic valve 7002 to the tricuspid annulus of the human heart. FIG.86A is an illustration of a first step of the delivery process in whicha guidewire 7085 with a hypotube sheath or secondary catheter 7080 isdelivered to the RVOT through the superior vena cava (SVC). Theguidewire 7085 has a diameter of about 0.035 in (or about 0.889 mm).

FIG. 86B shows a delivery catheter 7072 being advanced over theguidewire 7085 to and through the native tricuspid annulus to the rightventricle.

FIG. 86C shows the valve 7002 in a compressed configuration disposedwithin a capsule/compression catheter 7076. The capsule 7076 is loadedinto a proximal end of the delivery catheter 7072 and the valve 7002 iswithdrawn from the capsule 7076 into the delivery catheter 7072 forfurther advancement or the capsule 7076 is used to advance the valve7002 within the delivery catheter 7072, with the sheathed guidewire 7085threaded through the valve 7002 and providing a wire path to the RVOT,planned deployment location. The guidewire 7085 can extend through aguidewire collar element 7040 of the valve 7002 while the largercircumference of the hypotube sheath or secondary catheter 7080 relativeto an aperture of the guidewire collar element 7040 blocks passage ofthe hypotube sheath or secondary catheter 7080 through the guidewirecollar element 7040. The guidewire collar element 7040 can be coupled toa tension arm (e.g., a distal lower tension arm) 7032.

FIG. 86D shows the valve 7002 advanced up and expelled out of thedelivery catheter 7072 into the expanded configuration and deployed intothe native annulus by pushing on the outer sheath or secondary catheter7080 to pull the valve 7002 by the guidewire collar element (ball) 7040up the delivery catheter 7072 and into position. The tension arm ordistal lower tension arm 7032 is used as a mount for the guidewirecollar element (ball) 7040, to position the valve 7002 duringdeployment, and to provide subannular anchoring on the distal side.

FIG. 86E shows the pushing catheter or secondary catheter 7080 extendingfrom the delivery catheter 7072 and being used to push the proximal sideof the valve 7002 into position within the native annulus.

FIG. 86F shows withdrawal of the delivery system (e.g., the guidewire7085 and the delivery catheter 7072) and anchoring of a proximal side ofthe expanded valve 7002 to the native annular tissue. FIG. 86F shows theexpanded valve 7002 with an atrial sealing collar facing the atrium, avalve body (e.g., a lower tubular body portion) deployed within thenative annulus and extending from atrium to ventricle, the anchoringtension arm or distal lower tension arm 7032 extending subannularly intothe RVOT area, and the guidewire collar/ball 7040 at a distal end of thetension arm 7032. The guidewire 7085, the secondary catheter 7080, andthe delivery catheter 7072 are withdrawn.

FIG. 87A is an illustration of a trans-septal (femoral-IVC) delivery ofa low profile, e.g., 8-20 mm, side-loaded prosthetic mitral valve 7102FIG. 87A shows the valve 7102 partially housed within a deliverycatheter 7172, and partially ejected for deployment into the nativemitral annulus.

FIG. 87B is an illustration of the low profile, side-loaded, verticallycompressed prosthetic mitral valve 7102 shown housed in a compressedconfiguration within the delivery catheter 7172.

FIG. 87C is an illustration of the low profile, side-loaded prostheticmitral valve 7102 shown partially housed within the delivery catheter7172 and partially laterally ejected from the delivery catheter 7172 andpositioned for deployment against the anterior side of the native mitralannulus. FIG. 87C shows the valve 7102 partially expanded, with a flowcontrol component 7150 of the valve 7102 beginning to unfurl or expand.

FIG. 87D is an illustration of the low profile, side-loaded prostheticmitral valve 7102 shown ejected from the delivery catheter 7172 into theexpanded configuration and positioned against the anterior side of thenative mitral annulus. FIG. 87D shows a secondary catheter 7180 that canbe pushed to pull the valve 7102 through the delivery catheter 7172 andto eject the valve 7102 from the delivery catheter 7172. FIG. 87D showsthe valve 7102 in an expanded configuration, with the flow controlcomponent 7150 of the valve 7102 being unfurled and expanded.

FIG. 87E is an illustration of a side or plan view of a low profile,side-loaded prosthetic valve 7102 shown deployed into the native mitralannulus. FIG. 87E shows the valve 7102 in the expanded configuration,with the flow control component 7150 of the valve 7102 being unfurledand expanded, and shows the delivery system (e.g., the delivery catheter7172 and the secondary catheter 7180) withdrawn.

FIG. 88A is an illustration of a side perspective view of a valve 7202according to an embodiment, partially delivered to a native annulus. Thevalve 7202 is a rotational lock valve embodiment where the prostheticvalve 7202 is delivered to the native annulus with an off-setsub-annular tension arm/tab (e.g., a distal lower tension arm) 7232positioned below the native annulus, and an off-set supra-annulartension arm/tab (e.g., a distal upper tension arm) 7231 positioned abovethe native annulus, while the valve 7202 (or at least a tubular valveframe 7210 thereof) is partially rolled off-set from the annular planeabout a longitudinal axis.

FIG. 88B is an illustration of a side perspective view of a valve 7202showing the prosthetic valve 7202 delivered to the native annulus withthe off-set sub-annular tension arm/tab (e.g., the distal lower tensionarm) 7232 positioned below the native annulus, and the off-setsupra-annular tension arm/tab (e.g., the distal upper tension arm) 7231positioned above the native annulus, while the valve 7202 (or at leastthe tubular valve frame 7210) is partially rolled into a functional orfully deployed position parallel to the annular plane. Once the valve7202 is rolled into position, and the tension arms 7231 and 7232 arelocked against the supra-annular and subannular tissues, respectively.The valve 7210 can also be further anchored using traditional anchoringelements as disclosed herein. FIG. 88B also shows a flow controlcomponent

FIG. 89A is an illustration of a prosthetic valve 7302 according to anembodiment being delivered to tricuspid valve annulus. FIG. 89A shows awire-frame distal lower tension arm 7332 of the valve 7302 or valveframe being ejected from the delivery catheter 7372 and being directedthrough the annulus and towards the RVOT. FIG. 89A shows an embodimentof an accordion-compressed low profile valve 7302 and shows the distallower tension arm 7332 directed towards the anterior leaflet forplacement into the RVOT while the valve 7302 is in the compressedconfiguration within the delivery catheter 7372 or substantially withinthe delivery catheter 7372.

FIG. 89B shows the wire-frame distal lower tension arm 7332 and a distalupper tension arm 7331 ejected from the delivery catheter 7372, thedistal lower tension arm 7332 is directed through the native annulus andinto the RVOT, and the distal upper tension arm 7331 stays in asupra-annular position, causing a passive, structural anchoring of adistal side of the valve 7302 about the annulus. FIG. 89B also shows asteerable anchoring catheter or secondary catheter 7380 attached to aproximal anchoring tab 7330. While the valve 7302 is held in theexpanded configuration in a pre-seating position, the valve 7302 can beassessed, and once valve function and patient conditions are correct,the steerable anchoring catheter 7380 can be used to push a proximalside of the valve 7302 from its oblique angle relative to a nativeannular plane, down into the annulus. The steerable anchoring catheteror secondary catheter 7380 can then be used to install one or moreanchoring elements 7390.

FIG. 89C shows the entire valve 7302 ejected from the delivery catheter7372, the wire-frame distal lower tension arm 7332 directed through theannulus and into the RVOT, and the wire-frame distal upper tension arm7331 staying in a supra-annular position, and causing a passive,structural anchoring of the distal side of the valve 7302 about theannulus, and at least one tissue anchor 7390 anchoring the proximal sideof the valve 7302 into the annulus tissue.

FIGS. 90A-90C show a plan view of a tissue anchor 7490 having a head7491A and a screw 7491B that can be inserted and/or threaded into thenative annular tissue. The tissue anchor 7490 includes a floatingradio-opaque marker 7492 at a distal end of the tissue anchor 7490(e.g., at an end of the screw 7491B) and in contact with the atrialsurface of the annular tissue. FIG. 90B shows the screw 7491B of thetissue anchor 7490 being advanced into the annular tissue with theradio-opaque marker 7492 threaded onto the tissue anchor 7490 andmaintaining position on the atrial surface of the annular tissue. FIG.90C shows the tissue anchor 7490 completely advanced into the annulartissue such that the tissue anchor 740 and the threaded floatingradio-opaque marker 7492 are now adjacent, indicating the desired depth,tension, and/or plication of the tissue anchor 7490 with respect to theannular tissue.

FIGS. 91A-91D illustrate a plan view of various tissue anchorconfigurations. FIG. 91A shows a tissue anchor 7590 according to anembodiment having a straight thread and a constant pitch. FIG. 91B showsa tissue anchor 7690 according to an embodiment having a straight threadand a variable pitch. FIG. 91C shows a tissue anchor 7790 according toan embodiment having a tapered thread and a constant pitch. FIG. 91Dshows a tissue anchor 7890 according to an embodiment having a sunkentaper thread and a variable pitch.

FIGS. 92A-92D illustrate a process for clipping and/or anchoring a lowerprofile prosthetic valve 7902 to annular tissue such as, for example, aproximal or anterior side of the native annulus. FIG. 92A shows thevalve 7902 being inserted into the native valve annulus and the valve7902 having an integral anchor delivery conduit or channel 7997 with atissue anchor 7990 disposed in a lumen of anchor delivery conduit orchannel 7997 and an anchor delivery catheter or pusher 7998 attached tothe tissue anchor 7990.

FIG. 92B shows the valve 7902 completely deployed within the nativevalve annulus and the integral anchor delivery conduit or channel 7997with the anchor 7990 disposed in the lumen of the channel 7997 and theanchor delivery catheter or pusher 7998 attached to the anchor 7998.

FIG. 92C shows the anchor 7990 being pushed out of the lumen of theanchor delivery conduit or channel 7997 and into the annular tissue. Theanchor delivery catheter or pusher 7998 can be used to advance theanchor 7990 through the anchor delivery conduit or channel 7997.

FIG. 92D shows the anchor 7990 in a locked position after being pushedout of the lumen of the delivery conduit or channel 7997 (e.g., via theanchor delivery catheter or pusher 7998) and into the annular tissue,thus anchoring the proximal side of the low profile valve 7902 to theproximal or anterior side of the native annular tissue.

FIGS. 93A-93E illustrate a process for clipping and/or anchoring a lowerprofile prosthetic valve 8002 to annular tissue such as, for example, aproximal or anterior side of the native annulus.

FIG. 93A shows the valve 8002 completely deployed within the nativevalve annulus. FIG. 93A also shows delivery of an attachment wire 8093via an anchor delivery catheter or pusher 8098 with a clip or anchor8090 housed within the lumen of the anchor delivery catheter 8098. Theattachment wire 8093 is attached to a proximal or anterior side of theprosthetic valve 8002. The attachment wire 8093 is configured to engageor couple to the clip or anchor 8090 to couple the valve 8002 to theclip or anchor 8090.

FIG. 93B shows the anchor delivery catheter 8098 inserted into anintra-annular space and shows the attachment wire 8093 attached to theproximal or anterior side of the valve 8002. The clip or anchor 8090 ishoused within the lumen of the anchor delivery catheter 8098 and is notshown.

FIG. 93C shows a receiver element or portion 8094 of the clip or anchor8090 ejected from the anchor delivery catheter 8098 and positionedbehind tissue to be captured. The receiver element or portion 8094 isengaged with or connected to the attachment wire 8093.

FIG. 93D shows an anchoring element or portion 8095 of the clip oranchor 8090 piercing the annular tissue behind which the receiverelement or portion 8094 is positioned. The anchoring element or portion8095 is inserted through the annular tissue and into the receiverelement or portion 8094 of the clip or anchor 8090. The clip or anchor8090 or at least the receiving element or portion 8094 of the clip oranchor 8090 are attached to the low profile valve 8002 via theattachment wire 8093.

FIG. 93E shows the anchor element or portion 8095 of the clip or anchor8090 extending through the annular tissue. The receiver element orportion 8094 of the clip or anchor 8090 and the anchor element orportion 8095 of the clip or anchor 8090 are connected to each other andto the annular tissue and connected by the attachment wire 8093 to thelow profile valve 8002. The anchor delivery catheter 8098 is withdrawnand the clip or anchor 8090 remains.

FIG. 94 is a flowchart showing a method 8100 for orthogonal delivery ofan implantable prosthetic valve to a desired location in the bodyaccording to an embodiment. The method 8100 includes providing acompressible and expandable prosthetic valve, at 8101. The compressibleand expandable prosthetic valve can be any of the valves disclosedherein. For example, the compressible and expandable prosthetic valvecan be a valve (i) where the valve has a tubular frame with a flowcontrol component mounted within the tubular frame, (ii) where the valveor flow control component is configured to permit blood flow in a firstdirection through an inflow end of the valve and to block blood flow ina second direction, opposite the first direction, through an outflow endof the valve, (iii) where the valve is compressible and expandable andhas a long-axis oriented at an intersecting angle of between 45-135degrees to the first direction, and (iv) where the long-axis is parallelto a length-wise cylindrical axis of a delivery catheter used to deliverthe valve. A delivery catheter is advanced to the desired location inthe body, at 8102. The compressible and expandable prosthetic valve isdelivered, at 8103, wherein the compressible and expandable prostheticvalve has a height of about 5-60 mm and a diameter of about 25-80 mm.The valve is compressible to a compressed configuration duringintroduction or delivery into the body using a delivery catheter. Thecompressible and expandable prosthetic valve is released from thedelivery catheter, at 8104, wherein the valve is expandable to anexpanded configuration after being released from the delivery catheterfor implanting the valve in the desired location in the body.

FIG. 95 is a flowchart showing a method 8200 for orthogonally loading acompressible and expandable prosthetic valve into a delivery catheteraccording to an embodiment. The method 8200 includes providing acompressible and expandable prosthetic valve, at 8201. The compressibleand expandable prosthetic valve can be any of the valves disclosedherein. For example, the compressible and expandable prosthetic valvecan be a valve (i) where the valve has a tubular frame with a flowcontrol component mounted within the tubular frame, (ii) where the valveor flow control component is configured to permit blood flow in a firstdirection through an inflow end of the valve and to block blood flow ina second direction, opposite the first direction, through an outflow endof the valve, (iii) where the valve is compressible and expandable andhas a long-axis oriented at an intersecting angle of between 45-135degrees to the first direction, (iv) where the long-axis is parallel toa length-wise cylindrical axis of a delivery catheter used to deliverthe valve, and (v) where the valve has a height of about 5-60 mm and adiameter of about 25-80 mm. The compressible and expandable prostheticvalve is loaded into a tapering fixture or funnel attached to a deliverycatheter, to compress the valve to a compressed configuration forintroduction into the body using the delivery catheter for implanting ata desired location in the body, at 8202.

As described above with reference to FIGS. 1A and 1B, a transcatheterprosthetic valve can include a valve frame and a flow control componentthat are integral components or that are separate components coupledprior to delivery to the desired location in the body. Any of theprosthetic valves described herein, however, can include a valve frameand a flow control component that are separate components that aredelivered separately and coupled or mounted within the desired locationin the body. For example, a valve frame such as those described hereincan be compressed and delivered to the desired location in the body viaa delivery catheter. The frame can be released from the deliverycatheter and deployed, for example, in the annulus of the native valve.The frame is in the expanded configuration once released from thedelivery catheter, and thus, is deployed in the annulus of the nativevalve in the expanded configuration. A flow control component such asany of those described herein can then be delivered separately (e.g.,via the delivery catheter or a separate or secondary delivery catheter)and mounted into the deployed frame. In some implementations, such anarrangement can allow for a commercially available flow controlcomponents, which are deployed within any of the frames describedherein, which have been previously and/or separately deployed in thenative annulus.

Provided below is a discussion of certain aspects or embodiments oftranscatheter prosthetic valves, delivery systems, and/or deliverymethods. The transcatheter prosthetic valves (or aspects or portionsthereof), the delivery systems, and/or the delivery methods describedbelow with respect to specific embodiments can be substantially similarin at least form and/or function to the valve 102 and/or correspondingaspects of the valve 102, the delivery system used to deliver the valve102, and/or the delivery methods described above with reference to FIGS.1A-1F. Thus, certain aspects of the specific embodiments are notdescribed in further detail herein.

FIG. 96A is an illustration of an open cross-section view of a lowprofile, side-loaded prosthetic valve frame 8310 and shows an example ofa commercially available valve or flow control component 8350 mountedwithin a central aperture 8314 defined by an inner surface of frame8310.

FIG. 96B is an illustration of valve frame 8310 having a braid orlaser-cut construction. FIG. 96B shows a longer distal lower tension arm8332 for extending sub-annularly towards the RVOT (described in detailabove), and a shorter distal upper tension arm 8331 for extending overthe atrial floor (described in detail above). The tubular frame 8310shown in FIG. 96B is about 10 mm in height and the commerciallyavailable valve sleeve or flow control component 8350 received by theframe 8310 can extend about 10 mm below the bottom of the tubular frame8310 when received therein, resulting in a valve having a total heightof 20 mm.

FIG. 96C is an illustration of the valve frame 8310 having the braid orlaser-cut construction and the commercially available valve sleeve orflow control component 8350 in a compressed configuration within adelivery catheter 8372. FIG. 96C shows a secondary steerable catheter8380 attached to the valve frame 8310 and used for ejecting,positioning, and anchoring the valve frame 8310 within the nativeannulus. The secondary catheter 8310 can also be used to retrieve afailed deployment of the valve frame 8310. The valve frame 8310 can bedelivered to the native annulus with the valve sleeve or flow controlcomponent 8350 previously mounted therein such that the valve frame 8310and flow control component 8350 are delivered together or can bedelivered in separate processes.

FIG. 96D is an illustration of the valve frame 8310 having a braid orlaser-cut construction shown partially compressed within the deliverycatheter 8372, and partially ejected from the delivery catheter 8372.FIG. 96D shows that while the valve frame 8372 is still compressed thedistal lower tension arm 8332 can be manipulated through the leafletsand chordae tendineae to find a stable anterior-side lodgment for thedistal side of the valve frame 8310. FIG. 96D also shows that the valveframe 8310 without the valve sleeve or flow control component 8350showing that the frame 8310 can be delivered to the native annulus priorto and/or separate from the delivery of the flow control component 8350.

FIG. 96E is an illustration of the valve frame 8310 having the braid orlaser-cut construction and engaging the tissue on the anterior side ofthe native annulus with the curved distal sidewall of the tubular frame8310 sealing around the native annulus. FIG. 96E shows the valve frame8310 held by the steerable secondary catheter 8380 at an oblique anglewhile valve frame 8310 function is assessed. FIG. 96E shows that theflow control component 8350 has not be delivered to the native annulus.

FIG. 96F is an illustration of a prosthetic valve having the braid orlaser-cut tubular frame 8310 fully deployed into the tricuspid annulus.The distal side of the valve frame 8310 is shown engaging the tissue onthe anterior side of the native annulus with the curved distal sidewallof the tubular frame 8310 sealing around the native annulus, and withthe proximal sidewall tension-mounted into the posterior side of thenative annulus. FIG. 96F shows the valve sleeve or flow controlcomponent 8350 delivered to the native annulus (after the delivery ofthe valve frame 8310) and mounted in the valve frame 8310. The valvesleeve or flow control component 8350 can be a commercially availableflow control component.

FIG. 97A is an illustration of a valve frame 8410 according to anembodiment being delivered to tricuspid valve annulus. FIG. 97A showsthe valve frame 8410 having the braided/laser cut-wire frameconstruction with a distal lower tension arm 8432 that is ejected from adelivery catheter 8410 and directed through the annulus and towards theRVOT.

FIG. 97B shows the valve frame 8410 partially disposed within thedelivery catheter 8472 with the distal lower tension arm 8432 and thedistal upper tension arm 8431 ejected from the delivery catheter 8472.The distal lower tension arm 8432 is directed through the annulus andinto the RVOT. The distal upper tension arm 8432 is shown staying in asupra-annular position, and causing a passive, structural anchoring of adistal side of the valve frame 8410 about the annulus. FIG. 97B showsthat a steerable anchoring catheter or secondary catheter 8480 can holdthe valve frame 8410 at an oblique angle in a pre-attachment position,so that the valve frame 8410 can be assessed, and once valve framefunction and patient conditions are correct, the steerable anchoringcatheter or secondary catheter 8480 can push the proximal side of thevalve frame 8410 from its oblique angle, down into the native annulus.The steerable anchoring catheter or secondary catheter 8480 can thenoptionally install one or more anchoring elements.

FIG. 97C is an illustration of a valve frame 8410 showing the entirebraided/laser cut-frame 8410 ejected from the delivery catheter 8410.The distal lower tension arm 8432 is directed through the annulus andinto the RVOT. The distal upper tension arm 8431 stays in asupra-annular position, and causes a passive, structural anchoring ofthe distal side of the valve frame 8410 about the annulus. At least onetissue anchor (not shown) can be used to anchor the proximal side of thevalve frame 8410 into the annulus tissue. FIG. 97C shows how the openingor aperture of the frame 8410 can allow blood to flow through theaperture and can then have a commercial valve sleeve or flow controlcomponent 8450 secondarily delivered and deployed into the aperture andsecured to valve frame 8410.

FIG. 98A is an illustration of a valve frame 8510 according to anembodiment being delivered to tricuspid valve annulus. FIG. 98A showsthe frame 8510 having a braided/laser cut-wire frame construction with adistal lower tension arm ejected from a delivery catheter (not shown)and being directed toward and/or through the native annulus and towardsthe RVOT. Delivery of the valve frame 8510 can also include a valve orvalve frame assessment process.

FIG. 98B shows the braided/laser cut-wire frame 8510 with the distallower tension arm and a distal upper tension arm ejected from a deliverycatheter. The distal lower tension arm is directed through the annulusand into the RVOT. The distal upper tension arm stays in a supra-annularposition, and causes a passive, structural anchoring of the distal sideof the valve frame 8510 about the annulus. The valve frame 8510 can beheld at an oblique angle in a pre-attachment position (e.g., via asteerable anchoring catheter or secondary catheter, not shown), so thatthe valve frame 8510 can be assessed, and once valve frame function andpatient conditions are correct, the proximal side of the valve frame8510 can be pushed from its oblique angle, down into the native annulus.

FIG. 98C shows the entire braided/laser cut-frame valve frame 8510ejected from the delivery catheter, with the distal lower tension armdirected through the annulus and into the RVOT and the distal uppertension arm staying in a supra-annular position, and causing a passive,structural anchoring of the distal side of the valve frame 8510 aboutthe annulus. Although not shown, at least one tissue anchor can be usedto anchor the proximal side of the valve frame 8510 into the annulustissue. FIG. 98C shows how a commercial valve sleeve or flow controlcomponent 8550 can be secondarily deployed into the opening or apertureof the frame 8510.

FIG. 99A is an illustration of a commercial valve sleeve or flow controlcomponent 8650 that can be mounted within any of the frames disclosedherein.

FIG. 99B is an illustration of the commercial valve sleeve or flowcontrol component 8650 showing that the flow control component 8650 canbe mounted within the any of the frames disclosed herein using and/orhaving two rigid support posts 8652.

FIG. 99C is an illustration of a commercial valve sleeve or flow controlcomponent 8750A that can be mounted within any of the frames disclosedherein. The flow control component 8750A is shown as a three-panelembodiment.

FIG. 99D is an illustration of the commercial valve sleeve or flowcontrol component 8750B that can be mounted within any of the framesdisclosed herein. The flow control component 8750B is shown as athree-panel embodiment having three rigid support posts 8752.

FIG. 100 is an illustration of the heart and shows an approximatelocation of the valves, the left and right atrium, the left and rightventricles, and the blood vessels that enter and exit the chambers ofthe heart.

FIG. 101A is an illustration of a low profile, e.g., 8-20 mm,side-loaded valve frame 8810 shown in a vertically compressedconfiguration and housed within a delivery catheter 8872.

FIG. 101B shows the valve frame 8810 partially compressed and partiallyhoused within a delivery catheter 8872, and partially laterally ejectedfrom the delivery catheter 8872 and positioned for deployment againstthe anterior side of the annulus of a native valve, such as thetricuspid valve or mitral valve.

FIG. 101C shows the valve frame 8810 ejected from the delivery catheter8872 and positioned against the anterior side of the native annulus. Thevalve frame 8510 can be held at an oblique angle in a pre-attachmentposition via a steerable anchoring catheter or secondary catheter 8880,so that the valve frame 8510 can be assessed, and once valve framefunction and patient conditions are correct, the proximal side of thevalve frame 8810 can be pushed from its oblique angle, down into thenative annulus via the steerable anchoring catheter or secondarycatheter 8880.

FIG. 101D shows the valve frame 8810 deployed into the native annulus ofa heart valve.

FIGS. 101E-101G illustrate side views of a valve or flow controlcomponent 8850 that can be inserted into the deployed frame 8810. FIG.101E shows two alternate versions of flow control component 8850,secondarily deliverable by a suitable respective delivery catheter. Inthe embodiment on the left in FIG. 101E, the flow control component isself-expanding, and is delivered from the lumen of the delivery catheterand allowed to expand into the lumen or aperture of the valve frame8810. In the embodiment on the right in FIG. 101E, the flow controlcomponent is a commercially-approved transcatheter balloon expandableflow control component 8850, that is delivered on a balloon catheter8889, on which it can be expanded into the lumen or aperture of thevalve frame 8810. FIG. 101F shows that the self-expanding embodiment ofthe valve or flow control component 8850 is deployed in the valve frame8810 and allowed to expand to an expanded configuration within the lumenor aperture of the frame 8810. FIG. 101G shows that the balloonexpandable valve or flow control component 8850 can be verticallydeployed into the central lumen or aperture of the already (laterally,horizontally, orthogonally) deployed valve frame 8810.

FIGS. 102A-102D illustrate a process for delivering a co-axialtranscatheter prosthetic valve 8902 to the annulus of a native valve ofthe human heart. FIG. 102A shows the valve 8902 in a co-axial compressedconfiguration being loaded using a compression capsule or compressioncatheter 8976 into a distal end of a delivery catheter 8972. FIG. 102Ashows a hypotube or sheath (secondary catheter) 8980, a guidewire 8985threaded through a guidewire collar 8940 coupled to, for example, adistal tension arm. The compression capsule or catheter 8976 isconfigured to compress the co-axial prosthetic valve to a size suitablefor insertion into the delivery catheter 8972.

FIG. 102B shows the co-axial compressed valve 8902 being delivered tothe distal end of the delivery catheter 8972, with the hypotube orsecondary catheter 8980 and sheathed guidewire 8985 threaded through ordisposed within a channel-type guidewire collar 8940 attached, forexample, to a distal tension arm. The guidewire collar 8940 can includeand/or form a constriction or other feature configured to permitadvancement of the guidewire 8985 through the guidewire collar 8940 andto block advancement of the secondary catheter 8980, which can be usedto advance the valve 8902 within the delivery catheter 8972.

FIG. 102C shows the co-axial compressed valve 8902 partially expelledfrom the delivery catheter 8972, with a distal tension arm and/or thechannel-type guidewire collar 8940 being positioned into the ventricularoutflow tract of the native valve (e.g., the RVOT). The distal tensionarm can form and/or define the channel-type guidewire collar 8940,thereby combining the functions or features.

FIG. 102D shows that, once positioned, the self-expanding valve 8902 canbe completely expelled from the delivery catheter 8972 and deployed as aprosthetic valve similar to any of those disclosed herein.

FIGS. 103A-103G illustrate a process for delivering a co-axialtranscatheter prosthetic valve 9002 to the annulus of the tricuspidvalve of the human heart. FIG. 103A is an illustration of a first stepof the delivery process in which a guidewire 9085 with a hypotube sheathor secondary catheter 9080 is delivered to the RVOT through the superiorvena cava (SVC). The guidewire 9085 has a diameter of about 0.035 in (orabout 0.889 mm).

FIG. 103B shows a delivery catheter 9072 being advanced through the SVCover the guidewire 9085 to and through the native tricuspid annulus tothe right ventricle.

FIG. 103C shows the valve 9002 in a compressed configuration within acompression capsule 9076. The capsule 9076 can be used to compress thevalve 9002 to an extent that the compressed valve 9002 fits within thedelivery catheter 9072. FIG. 103C shows the capsule 9076 is loaded intothe proximal end of the delivery catheter 9072 and the valve 9002 iswithdrawn/delivered from the capsule 9076 into the delivery catheter9072, with sheathed guidewire 9085 threaded through the valve 9002 andproviding a wire path to the RVOT, planned deployment location.

FIG. 103D shows the valve 9002 advanced up the delivery catheter 9072and deployed into the native annulus by pushing on the outer hypotubesheath or secondary catheter 9080 to pull the valve 9002 up the deliverycatheter 9072 and into position. FIG. 103D shows a tension arm 9030 ofthe valve 9002 is used to position the valve 9002 in the native annulus.

FIG. 103E shows a steerable balloon catheter 9089 being used to push theproximal side of the valve 9002 in the expanded configuration intoposition within the native annulus.

FIG. 103F shows balloon expansion of the co-axial valve 9002 in thenative annulus. The proximal side of the valve 9002 can be anchored tothe annular tissue.

FIG. 103G shows withdrawal of the delivery system (e.g., the deliverycatheter 9072, the secondary catheter 9080, the guidewire 9085, etc.).The proximal side of the expanded valve 9002 is anchored to the annulartissue using any of the anchoring methods described herein.

FIGS. 104A-104F illustrate a process for delivering a co-axialballoon-expandable transcatheter prosthetic valve 9102 to the tricuspidannulus of the human heart. FIG. 104A shows a delivery catheter 9172advanced over a guidewire 9185 to be deployed to the native annulus.

FIG. 104B shows the co-axial balloon-expandable valve 9102 in acompressed configuration within a compression capsule 9176. The capsule9176 can be used to compress the valve 9102 to an extent that thecompressed valve 9102 fits within the delivery catheter 9172. FIG. 104Bshows the capsule 9176 is loaded into the proximal end of the deliverycatheter 9172 and the valve 9102 is withdrawn/delivered from the capsule9176 into the delivery catheter 9172, with the sheathed guidewire 9085threaded through the valve 9102 and providing a wire path to the RVOT,planned deployment location. FIG. 104B shows the valve 9102 including achannel-type guidewire collar 9140 through which the guidewire 9185 isthreaded.

FIG. 104C shows the co-axial valve 9102 being delivered to the proximalend of the delivery catheter 9172, with the sheathed guidewire 9180threaded through the tension arm and/or guidewire collar 9140. Theguidewire collar 9140 can couple to or can at least partially form adistal tension arm. The guidewire collar 9140 can include and/or form aconstriction or other feature configured to permit advancement of theguidewire 9185 through the guidewire collar 9140 and to blockadvancement of a hypotube sheath or secondary catheter 9180, which canbe used to advance the valve 9102 within the delivery catheter 9172.

FIG. 104D shows the co-axial valve 9102 partially expelled from thedelivery catheter 9172 into the expanded configuration, with the distaltension arm and/or guidewire collar 9140 being positioned into the RVOT.FIG. 104D shows a balloon catheter 9189 connected to the valve 9102.

FIG. 104E shows that, once positioned and expanded by the ballooncatheter 9189, the balloon-expanded co-axial valve 9102 can becompletely deployed into the inner circumference of the native annulusto function as a prosthetic valve. FIG. 104F shows the deployed valve9102 with the delivery system (e.g., the delivery catheter 9172,secondary catheter 9180, guidewire 9185, balloon catheter 9189, etc.)withdrawn.

FIG. 104F is an illustration of step 6 of a 6-step process for deliveryof a co-axial prosthetic valve 143 to the tricuspid annulus. FIG. 104Fshows the deployed valve.

Example. One embodiment of an orthogonally delivered transcatheterprosthetic valve has a tubular frame with a flow control componentmounted within the tubular frame and configured to permit blood flow ina first direction through an inflow end of the valve and block bloodflow in a second direction, opposite the first direction, through anoutflow end of the valve, wherein the valve is compressible to acompressed configuration for introduction into the body using a deliverycatheter for implanting at a desired location in the body, saidcompressed configuration having a long-axis oriented at an intersectingangle of between 45-135 degrees to the first direction, and expandableto an expanded configuration having a long-axis oriented at anintersecting angle of between 45-135 degrees to the first direction,wherein the long-axis of the compressed configuration of the valve issubstantially parallel to a lengthwise cylindrical axis of the deliverycatheter, wherein the valve has a height of about 5-60 mm and a diameterof about 25-80 mm. Importantly, this heart valve substitute does nothave a traditional valve configuration, can be delivered to the heartusing the inferior vena cava (IVC/femoral transcatheter delivery pathwaycompressed within a catheter, and expelled from the catheter to bedeployed without open-heart surgery.

Example. In another embodiment of a transcatheter valve, comprises: acylindrical tubular frame having a height of about 5-60 mm and an outerdiameter of about 25-80 mm, said tubular frame comprised of a braid,wire, or laser-cut wire frame having a substantially circular centralaperture, said tubular frame partially covered with a biocompatiblematerial; a collapsible flow control component disposed within thecentral aperture, said sleeve having a height of about 5-60 mm andcomprised of at least two opposing leaflets that provide a reciprocatingclosable channel from a heart atrium to a heart ventricle; an uppertension arm attached to a distal upper edge of the tubular frame, theupper tension arm comprised of stent, segment of tubular frame, wireloop or wire frame extending from about 10-30 mm away from the tubularframe; a lower tension arm extending from a distal side of the tubularframe, the lower tension arm comprised of stent, segment of tubularframe, wire loop or wire frame extending from about 10-40 mm away fromthe tubular frame; and at least one tissue anchor to connect the tubularframe to native tissue.

Example. In another embodiment of a transcatheter valve, there isprovided a feature wherein the sleeve is shaped as a conic cylinder,said top end having a diameter of 30-35 mm and said bottom end having adiameter of 8-20 mm.

Example. In another embodiment of a transcatheter valve, there isprovided a feature wherein the cover is comprised of polyester,polyethylene terephthalate, decellularized pericardium, or a layeredcombination thereof.

Example. In an embodiment, there is also provided a method fororthogonal delivery of implantable prosthetic valve to a desiredlocation in the body, wherein the method includes (i) advancing adelivery catheter to the desired location in the body and delivering anexpandable prosthetic valve to the desired location in the body byreleasing the valve from the delivery catheter, wherein the valvecomprises a tubular frame having a flow control component mounted withinthe tubular frame and configured to permit blood flow in a firstdirection through an inflow end of the valve and block blood flow in asecond direction, opposite the first direction, through an outflow endof the valve, wherein the valve is compressible to a compressedconfiguration for introduction into the body using a delivery catheterfor implanting at a desired location in the body, said compressedconfiguration having a long-axis oriented at an intersecting angle ofbetween 45-135 degrees to the first direction, and expandable to anexpanded configuration having a long-axis oriented at an intersectingangle of between 45-135 degrees to the first direction, wherein thelong-axis of the compressed configuration of the valve is substantiallyparallel to a lengthwise cylindrical axis of the delivery catheter,wherein the valve has a height of about 5-60 mm and a diameter of about25-80 mm.

Example. In an embodiment, there is also provided a method fororthogonally loading an implantable prosthetic valve into a deliverycatheter, where the method includes loading an implantable prostheticvalve sideways into a tapering fixture or funnel attached to a deliverycatheter, wherein the valve comprises a tubular frame having a flowcontrol component mounted within the tubular frame and configured topermit blood flow in a first direction through an inflow end of thevalve and block blood flow in a second direction, opposite the firstdirection, through an outflow end of the valve, wherein the valve iscompressible to a compressed configuration for introduction into thebody using a delivery catheter for implanting at a desired location inthe body, said compressed configuration having a long-axis oriented atan intersecting angle of between 45-135 degrees to the first direction,and expandable to an expanded configuration having a long-axis orientedat an intersecting angle of between 45-135 degrees to the firstdirection, wherein the long-axis of the compressed configuration of thevalve is substantially parallel to a lengthwise cylindrical axis of thedelivery catheter, wherein the valve has a height of about 5-60 mm and adiameter of about 25-80 mm.

Example. In an embodiment, there is also provided a method fororthogonally loading an implantable prosthetic valve into a deliverycatheter, where the method includes (i) loading an implantableprosthetic valve into a tapering fixture or funnel attached to adelivery catheter, wherein the valve comprises a tubular frame having aflow control component mounted within the tubular frame and configuredto permit blood flow in a first direction through an inflow end of thevalve and block blood flow in a second direction, opposite the firstdirection, through an outflow end of the valve, wherein said loading isperpendicular or substantially orthogonal to the first direction,wherein the valve is compressible to a compressed configuration forintroduction into the body using a delivery catheter for implanting at adesired location in the body, said compressed configuration having along-axis oriented at an intersecting angle of between 45-135 degrees tothe first direction, and expandable to an expanded configuration havinga long-axis oriented at an intersecting angle of between 45-135 degreesto the first direction, wherein the long-axis of the compressedconfiguration of the valve is substantially parallel to a lengthwisecylindrical axis of the delivery catheter, wherein the valve has aheight of about 5-60 mm and a diameter of about 25-80 mm.

Example. The transcatheter prosthetic heart valve may be percutaneouslydelivered using a transcatheter process via the femoral through the IVC,carotid, sub-xiphoid, intercostal access across the chest wall, andtrans-septal to the mitral annulus through the fossa ovalis. The deviceis delivered via catheter to the right or left atrium and is expandedfrom a compressed shape that fits with the internal diameter of thecatheter lumen. The compressed valve is loaded external to the patientinto the delivery catheter and is then pushed out of the catheter whenthe capsule arrives to the atrium. The cardiac treatment technicianvisualizes this delivery using available imaging techniques such asfluoroscopy or ultrasound, and in an embodiment, the valve self-expandsupon release from the catheter since it is constructed in part fromshape-memory material, such as Nitinol®, a nickel-titanium alloy used inbiomedical implants.

In another embodiment, the valve may be constructed of materials thatrequires balloon-expansion after the capsule has been ejected from thecatheter into the atrium.

The atrial collar/frame and the flow control component are expanded totheir functional diameter, as they are deployed into the native annulus,providing a radial tensioning force to secure the valve. Once the frameis deployed about the tricuspid annulus, fasteners secure the deviceabout the native annulus. Additional fastening of the device to nativestructures may be performed, and the deployment is complete. Furtheradjustments using hemodynamic imaging techniques are contemplated toensure the device is secure, is located and oriented as planned, and isfunctioning as a substitute or successor to the native tricuspid valve.

Example—One embodiment of an orthogonally delivered transcatheterprosthetic valve frame has a tubular frame, wherein the valve frame iscompressible to a compressed configuration for introduction into thebody using a delivery catheter for implanting at a desired location inthe body, said compressed configuration having a long-axis oriented atan intersecting angle of between 45-135 degrees to the central,cylindrical axis of the native annulus, and expandable to an expandedconfiguration having a long-axis oriented at an intersecting angle ofbetween 45-135 degrees to the central, cylindrical axis of the nativeannulus, wherein the long-axis of the compressed configuration of thevalve is substantially parallel to a lengthwise cylindrical axis of thedelivery catheter, wherein the valve has a height of about 5-60 mm and adiameter of about 25-80 mm. This heart valve frame can be delivered tothe heart using the inferior vena cava (IVC/femoral transcatheterdelivery pathway compressed within a catheter and expelled from thecatheter to be deployed without open-heart surgery.

Example—In another embodiment of a transcatheter valve frame, acylindrical tubular frame is provided having a height of about 5-60 mmand an outer diameter of about 25-80 mm, said tubular frame comprised ofa braid, wire, or laser-cut wire frame having a substantially circularcentral aperture, said tubular frame partially covered with abiocompatible material; an upper tension arm attached to a distal upperedge of the tubular frame, the upper tension arm comprised of stent,segment of tubular frame, wire loop or wire frame extending from about10-30 mm away from the tubular frame; a lower tension arm extending froma distal side of the tubular frame, the lower tension arm comprised ofstent, segment of tubular frame, wire loop or wire frame extending fromabout 10-40 mm away from the tubular frame; and at least one tissueanchor to connect the tubular frame to native tissue.

Example—In an embodiment, there is also provided a method for orthogonaldelivery of implantable prosthetic valve frame to a desired location inthe body, where the method includes (i) advancing a delivery catheter tothe desired location in the body and delivering an expandable prostheticvalve frame to the desired location in the body by releasing the valveframe from the delivery catheter, wherein the valve frame iscompressible to a compressed configuration for introduction into thebody using a delivery catheter for implanting at a desired location inthe body, said compressed configuration having a long-axis oriented atan intersecting angle of between 45-135 degrees to the central,cylindrical axis of the native annulus, and expandable to an expandedconfiguration having a long-axis oriented at an intersecting angle ofbetween 45-135 degrees to the central, cylindrical axis of the nativeannulus, wherein the long-axis of the compressed configuration of thevalve frame is substantially parallel to a lengthwise cylindrical axisof the delivery catheter, wherein the valve frame has a height of about5-60 mm and a diameter of about 25-80 mm.

Example—In an embodiment, there is also provided a method fororthogonally loading an implantable prosthetic valve frame into adelivery catheter, where the method includes loading an implantableprosthetic valve frame sideways into a tapering fixture or funnelattached to a delivery catheter, wherein the valve frame is compressibleto a compressed configuration for introduction into the body using adelivery catheter for implanting at a desired location in the body, saidcompressed configuration having a long-axis oriented at an intersectingangle of between 45-135 degrees to the central, cylindrical axis of thenative annulus, and expandable to an expanded configuration having along-axis oriented at an intersecting angle of between 45-135 degrees tothe central, cylindrical axis of the native annulus, wherein thelong-axis of the compressed configuration of the valve frame issubstantially parallel to a lengthwise cylindrical axis of the deliverycatheter, wherein the valve frame has a height of about 5-60 mm and adiameter of about 25-80 mm.

Example—The transcatheter prosthetic heart valve may be percutaneouslydelivered using a transcatheter process via the femoral through theinferior vena cava (IVC), superior vena cava (SVC), jugular vein,brachial vein, sub-xiphoid, intercostal access across the chest wall,and trans-septal through the fossa ovalis. The device is delivered viacatheter to the right or left atrium and is expanded from a compressedshape that fits with the internal diameter of the catheter lumen. Thecompressed valve is loaded external to the patient into the deliverycatheter and is then pushed out of the catheter when the capsule arrivesto the atrium. The cardiac treatment technician visualizes this deliveryusing available imaging techniques such as fluoroscopy or ultrasound,and in an embodiment the valve frame self-expands upon release from thecatheter since it is constructed in part from shape-memory material,such as Nitinol®, a nickel-titanium alloy used in biomedical implants.

In another embodiment, the valve frame may be constructed for use withballoon-expansion after the capsule has been ejected from the catheterinto the atrium. The atrial collar/frame is expanded to their functionaldiameter, and deployed into the native annulus, providing a radialtensioning force to secure the valve frame. Once the frame is deployedabout the tricuspid annulus, fasteners secure the device about thenative annulus. Additional fastening of the device to native structuresmay be performed, and the deployment is complete. Further adjustmentsusing hemodynamic imaging techniques are contemplated in order to ensurethe device is secure, is located and oriented as planned, and isfunctioning.

Example—Compression methods. In another embodiment, there is provided amethod of compressing, wherein the implantable prosthetic heart valve isrolled or folded into a compressed configuration using at least one of(i) unilaterally rolling into a compressed configuration from one sideof the annular support frame; (ii) bilaterally rolling into a compressedconfiguration from two opposing sides of the annular support frame;(iii) flattening the annular support frame into two parallel panels thatare substantially parallel to the long-axis, and then rolling theflattened annular support frame into a compressed configuration; and(iv) flattening the annular support frame along a vertical axis toreduce a vertical dimension of the valve from top to bottom.

Many modifications and variations can be made without departing from itsspirit and scope, as will be apparent to those skilled in the art.Functionally equivalent methods and apparatuses within the scope of thedisclosure, in addition to those enumerated herein, will be apparent tothose skilled in the art from the foregoing descriptions. Suchmodifications and variations are intended to fall within the scope ofthe appended claims. The present disclosure is to be limited only by theterms of the appended claims, along with the full scope of equivalentsto which such claims are entitled. It is to be understood that thisdisclosure is not limited to particular methods, reagents, compounds,compositions or biological systems, which can, of course, vary. It isalso to be understood that the terminology used herein is for thepurpose of describing particular embodiments only and is not intended tobe limiting.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

Where schematics and/or embodiments described above indicate certaincomponents arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Any portion of theapparatus and/or methods described herein may be combined in anycombination, except mutually exclusive combinations. The embodimentsdescribed herein can include various combinations and/orsub-combinations of the functions, components, and/or features of thedifferent embodiments described.

What is claimed is:
 1. A prosthetic valve, comprising: a valve framehaving a central axis and defining an aperture extending along thecentral axis, the frame having a tension arm extending laterallytherefrom; and a flow control component mounted within the aperture andconfigured to permit blood flow in a first direction approximatelyparallel to the central axis from an inflow end to an outflow end of theflow control component and block blood flow in a second direction,opposite the first direction, the frame having an expanded configurationwith a first height along the central axis, a first lateral width alonga lateral axis perpendicular to the central axis, and a firstlongitudinal length along a longitudinal axis perpendicular to thecentral axis and the lateral axis, the frame in the expandedconfiguration being configured to be disposable in an annulus of anative valve between an atrium of a heart and a ventricle of the heart,with a portion of the frame including the tension arm being disposedbelow the annulus in the ventricle, the frame having a compressedconfiguration with a second height, less than the first height, alongthe central axis and a second lateral width, less than the first lateralwidth, along the lateral axis.
 2. The prosthetic valve of claim 1,wherein the compressed configuration of the valve frame has a secondlongitudinal length, greater than the first longitudinal length, alongthe longitudinal axis.
 3. The prosthetic valve of claim 1, wherein thevalve frame can be changed from the expanded configuration to thecompressed configuration by compressing the valve frame vertically byone or more of flattening, rolling, or folding the valve frame, and bycompressing the valve frame laterally by one or more of flattening,rolling, or folding the valve frame.
 4. The prosthetic valve of claim 1,wherein the valve frame includes two panels and the valve frame can bechanged from the expanded configuration to the compressed configurationby compressing the valve frame laterally by flattening the valve framealong the lateral axis so that the two panels are approximatelyparallel, and compressing the valve frame vertically by rolling theflattened valve frame along the central axis and about the longitudinalaxis.
 5. A system including the prosthetic valve of claim 1, furthercomprising: a delivery catheter having a lumen, the lumen having adiameter less than the first height of the valve frame, less than thefirst lateral width of the valve frame, greater than the second heightof the valve frame, and greater than the second lateral width of thevalve frame; the valve frame being in the compressed configuration andthe prosthetic valve disposed in the lumen of the delivery catheter. 6.The system of claim 5, further comprising: a capsule having an outerdiameter and a lumen having an inner diameter, the outer diameter of thecapsule being less than the inner diameter of the lumen of the deliverycatheter, the inner diameter of the lumen of the capsule being less thanthe first height of the valve frame, less than the first lateral widthof the valve frame, greater than the second height of the valve frame,and greater than the second lateral width of the valve frame; theprosthetic valve disposable in the lumen of the capsule; and the capsuledisposable in the lumen of the delivery catheter.
 7. The system of claim5, wherein the valve frame includes a guidewire collar having anaperture therethrough, the aperture of the guidewire collar having aninternal diameter, the system further comprising: a pusher having adistal end and a diameter larger than the internal diameter of theaperture of the guidewire collar, the pusher disposable over a guidewiredisposable through the aperture of the guidewire collar and the lumen ofthe delivery catheter, with the distal end of the pusher engageable withthe guidewire collar.
 8. A method of delivering a prosthetic valve to anannulus of a native valve between a ventricle and an atrium of a heart,the method comprising: disposing in the atrium of the heart a distalportion of a delivery catheter having a lumen and a longitudinal axis,with a distal end of the delivery catheter directed towards the annulusof the native valve, the distal portion of the delivery catheter havingdisposed within the lumen thereof the prosthetic valve in a compressedconfiguration, the prosthetic valve having a tubular frame with anupper, atrial edge and a lower, ventricular edge having a first portionwith a tension arm coupled thereto and a second portion spaced from thefirst portion, and a flow control component mounted within the tubularframe and having an expanded configuration in which the prosthetic valveis configured to permit blood flow in a first direction through aninflow end of the prosthetic valve and block blood flow in a seconddirection, opposite the first direction, through an outflow end of theprosthetic valve and the tension arm extends laterally from the tubularframe and is configured to be disposed on the ventricle side of theannulus of the native valve when the tubular frame is disposed withinthe annulus, the tubular frame disposed within the lumen of the deliverycatheter with the tension arm disposed towards the distal end of thedelivery catheter; releasing the tension arm from the lumen of thedelivery catheter; disposing at least a distal portion of the tensionarm on the ventricle side of the annulus of the native valve while thedistal end of the delivery catheter and the second portion of the lower,ventricular edge of the tubular frame remains on the atrium side of theannulus; releasing the remainder of the prosthetic valve from the lumenof the delivery catheter; and seating the prosthetic valve in theannulus.
 9. The method of claim 8, wherein the seating the prostheticvalve in the annulus includes disposing the tubular frame of theprosthetic valve fully within the annulus of the native valve with thesecond portion of the lower, ventricular edge of the tubular framedisposed on the ventricle side of the annulus.
 10. The method of claim8, wherein prior to the seating the prosthetic valve in the annulus, themethod further comprising: holding the prosthetic valve at an obliqueangle relative to the annulus of the native valve; and allowing blood toflow from the atrium to the ventricle both through the native valve andthrough the prosthetic valve to allow assessment of the function of thenative valve and the prosthetic valve.
 11. A method for preparing aprosthetic valve for delivery to a patient by a delivery catheter havinga lumen with a lumen diameter, the prosthetic valve having an annularvalve frame defining a central axis and having an expanded configurationwith a vertical height along the central axis, a lateral width along alateral axis perpendicular to the central axis, and a longitudinallength along a longitudinal axis perpendicular to the central axis andthe lateral axis, the valve frame having a tension arm extendinglaterally therefrom and configured to be disposed on the ventricle sideof the annulus of the native valve when the valve frame is disposedwithin the annulus, the method comprising: compressing the valve framevertically by reducing the dimension of the valve frame along thecentral axis from the expanded configuration to a dimension less thanthe lumen diameter; compressing the valve frame laterally by reducingthe dimension of the valve frame along the lateral axis from theexpanded configuration to a dimension less than the lumen diameter, thecompressing the valve frame vertically and the compressing the valveframe laterally collectively disposing the valve frame in a compressedconfiguration; and inserting the valve frame in the compressedconfiguration into the lumen of the delivery catheter.
 12. The method ofclaim 11, wherein the compressing the valve frame vertically includesone or more of flattening, rolling, or folding the valve frame.
 13. Themethod of claim 12, wherein the valve frame includes two panels, thecompressing the valve frame laterally includes flattening the valveframe along the lateral axis so that the two panels are approximatelyparallel, and the compressing the valve frame vertically includesrolling the flattened valve frame along the vertical axis.
 14. Themethod of claim 11, wherein the compressing the valve frame laterallyincludes one or more of flattening, rolling, or folding the valve frame.15. The method of claim 14, wherein the compressing the valve framelaterally includes rolling the valve frame along the lateral axis one ofunilaterally from one side of the valve frame or bilaterally from bothsides of the valve frame.
 16. The method of claim 11, wherein theinserting the valve frame includes inserting the valve frame into acapsule and inserting the capsule into the lumen of the deliverycatheter.
 17. The method of claim 11, wherein the valve frame includes aguidewire collar having an aperture therethrough, the aperture having aninternal diameter, the method further comprising: disposing the valveframe over a guidewire having a diameter smaller than the internaldiameter of the aperture of the guidewire collar; and disposing over theguidewire a pusher having a distal end and a diameter larger than theinternal diameter of the aperture of the guidewire collar, with thedistal end of the pusher engaged with the guidewire collar.
 18. A methodof delivering a prosthetic valve to an annulus of a native valve betweena ventricle and an atrium of a heart, the method comprising: disposingin the atrium of the heart a distal portion of a delivery catheter, witha distal end of the delivery catheter directed towards the annulus ofthe native valve, the distal portion of the delivery catheter havingdisposed within a lumen thereof the prosthetic valve in a compressedconfiguration, the prosthetic valve having a tubular frame with anupper, atrial edge having a proximal portion and a distal portion and alower, ventricular edge having a proximal portion and a distal portion,a distal lower tension arm coupled to the distal portion of the lower,ventricular edge and a distal upper tension arm coupled to the distalportion of the upper, atrial edge and a flow control component mountedwithin the tubular frame, the prosthetic valve having an expandedconfiguration in which the flow control component permits blood flowthrough the prosthetic valve in a first direction and blocks blood flowthrough the prosthetic valve in a second direction, opposite the firstdirection, the prosthetic valve disposed within the lumen of thedelivery catheter with the distal lower tension arm and the distal uppertension arm disposed towards the distal end of the delivery catheter;releasing the distal lower tension arm from the lumen of the deliverycatheter; releasing the distal upper tension arm from the lumen of thedelivery catheter; placing a portion of the distal lower tension arm onthe ventricle side of the annulus of the native valve while the distalupper tension arm and the proximal portion of the lower, ventricularedge remains on the atrium side of the annulus; and after the placingthe portion of the distal lower tension arm on the ventricle side of theannulus: releasing the remainder of the prosthetic valve from the lumenof the delivery catheter; and deploying the prosthetic valve into, andsecuring the prosthetic valve to, the annulus of the native valve, thedistal upper tension arm being in contact with supra-annular tissue onthe atrium side of the annulus and the distal lower tension arm being incontact with subannular tissue on the ventricle side of the annulusduring the deploying.
 19. The method of claim 18, further comprising:placing a proximal tension arm attached to a proximal side wall of thetubular frame in contact with annular tissue on a proximal side of thenative valve; and anchoring the proximal tension arm to the annulartissue on the proximal side of the native valve via at least one tissueanchor.
 20. The method of claim 18, further comprising: rotating theprosthetic valve using a steerable catheter along an axis parallel to aplane of the annulus of the native valve so that the distal uppertension arm is conformationally pressure locked against thesupra-annular tissue on the atrium side of the annulus and the distallower tension arm is conformationally pressure locked against thesubannular tissue on the ventricle side of the annulus.
 21. The methodof claim 18, wherein the native valve is a tricuspid valve, the atriumis the right atrium, and the ventricle is the right ventricle, theplacing the portion of the distal lower tension arm includes disposingthe portion of the tension arm into a right ventricular outflow tract ofthe right ventricle.
 22. The method of claim 18, wherein the distalupper tension arm provides a force on the supra-annular tissue in thedirection of the ventricle and distal lower tension arm provides a forceon the subannular tissue in the direction of the atrium during thedeploying.